Trial Outcomes & Findings for Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia (NCT NCT00830167)
NCT ID: NCT00830167
Last Updated: 2021-01-25
Results Overview
Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain).
COMPLETED
PHASE3
498 participants
Baseline, Week 15 or study discontinuation
2021-01-25
Participant Flow
Participants were administered placebo tablet in single blind manner and evaluated for the inclusion/exclusion criteria during the 1-week screening phase. Participants who demonstrated a high response to placebo, i.e., \<=30% decrease on the VAS, were discontinued from the study at the end of the screening phase.
Participant milestones
| Measure |
Placebo
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Overall Study
STARTED
|
248
|
250
|
|
Overall Study
COMPLETED
|
208
|
207
|
|
Overall Study
NOT COMPLETED
|
40
|
43
|
Reasons for withdrawal
| Measure |
Placebo
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
26
|
10
|
|
Overall Study
Adverse Event
|
8
|
24
|
|
Overall Study
Not meeting entrance criteria
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
Total
n=498 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
Between 18 years and 44 years
|
104 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Age, Customized
Between 45 years and 64 years
|
123 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=99 Participants
|
226 Participants
n=107 Participants
|
443 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
|
-1.03 Scores on a scale
Standard Error 0.12
|
-1.48 Scores on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication.
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Percentage of Participants Who Was Categorized as "Improved (Very Much Improved, Much Improved, or a Minimally Improved)" According to the Patient Global Impressions of Change (PGIC)
|
62.1 Percentage of participants
|
70.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance
|
-8.13 Scores on a scale
Standard Error 1.31
|
-17.62 Scores on a scale
Standard Error 1.31
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring
|
-1.61 Scores on a scale
Standard Error 1.33
|
3.37 Scores on a scale
Standard Error 1.33
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache
|
-3.02 Scores on a scale
Standard Error 1.36
|
-8.01 Scores on a scale
Standard Error 1.36
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep
|
0.17 Scores on a scale
Standard Error 0.06
|
0.46 Scores on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy
|
8.02 Scores on a scale
Standard Error 1.41
|
15.50 Scores on a scale
Standard Error 1.40
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence
|
-4.66 Scores on a scale
Standard Error 1.29
|
6.65 Scores on a scale
Standard Error 1.28
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index
|
-7.07 Scores on a scale
Standard Error 0.96
|
-10.06 Scores on a scale
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint
|
53 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Sleep Quality Score at Endpoint
|
-0.79 Scores on a scale
Standard Error 0.12
|
-1.52 Scores on a scale
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores
|
-7.26 Scores on a scale
Standard Error 1.08
|
-10.59 Scores on a scale
Standard Error 1.07
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function
|
-0.19 Scores on a scale
Standard Error 0.11
|
-0.47 Scores on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good
|
-0.82 Scores on a scale
Standard Error 0.17
|
-1.45 Scores on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss
|
-0.30 Scores on a scale
Standard Error 0.15
|
-0.31 Scores on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework
|
-1.00 Scores on a scale
Standard Error 0.15
|
-1.32 Scores on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain
|
-1.06 Scores on a scale
Standard Error 0.15
|
-1.46 Scores on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness
|
-0.94 Scores on a scale
Standard Error 0.14
|
-1.43 Scores on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning
|
-0.97 Scores on a scale
Standard Error 0.15
|
-1.56 Scores on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness
|
-0.90 Scores on a scale
Standard Error 0.15
|
-1.05 Scores on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious
|
-0.64 Scores on a scale
Standard Error 0.16
|
-0.92 Scores on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression
|
-0.51 Scores on a scale
Standard Error 0.14
|
-0.55 Scores on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning
|
4.72 Scores on a scale
Standard Error 0.93
|
9.01 Scores on a scale
Standard Error 0.93
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical
|
8.36 Scores on a scale
Standard Error 1.30
|
10.04 Scores on a scale
Standard Error 1.30
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain
|
9.50 Scores on a scale
Standard Error 1.06
|
11.65 Scores on a scale
Standard Error 1.06
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception
|
2.83 Scores on a scale
Standard Error 0.85
|
4.66 Scores on a scale
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning
|
6.84 Scores on a scale
Standard Error 1.38
|
8.43 Scores on a scale
Standard Error 1.37
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional
|
3.50 Scores on a scale
Standard Error 1.36
|
3.27 Scores on a scale
Standard Error 1.35
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality
|
5.12 Scores on a scale
Standard Error 1.22
|
9.53 Scores on a scale
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health
|
3.33 Scores on a scale
Standard Error 0.98
|
5.97 Scores on a scale
Standard Error 0.98
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety
|
-0.09 Scores on a scale
Standard Error 0.18
|
-0.57 Scores on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition.
Outcome measures
| Measure |
Placebo
n=247 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=249 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression
|
0.00 Scores on a scale
Standard Error 0.20
|
-0.29 Scores on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, Week 15 or study discontinuationPopulation: The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.
The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline.
Outcome measures
| Measure |
Placebo
n=248 Participants
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 Participants
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint
|
-14.11 Scores on a scale
Standard Error 1.45
|
-20.30 Scores on a scale
Standard Error 1.44
|
Adverse Events
Placebo
Pregabalin
Serious adverse events
| Measure |
Placebo
n=248 participants at risk
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 participants at risk
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Placebo
n=248 participants at risk
Placebo was administered twice a day for 15 weeks.
|
Pregabalin
n=250 participants at risk
Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant's individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
|
|---|---|---|
|
Eye disorders
Vision blurred
|
1.2%
3/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
5.2%
13/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
6.9%
17/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
14.4%
36/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling abnormal
|
1.2%
3/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
8.0%
20/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
1.2%
3/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.2%
18/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
18.1%
45/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
18.0%
45/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
3.6%
9/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
15.6%
39/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
6.0%
15/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
29.6%
74/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
6.0%
15/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
6.0%
15/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
18.1%
45/248
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
46.4%
116/250
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER