Trial Outcomes & Findings for Pramipexole ER vs. Placebo in Fibromyalgia (NCT NCT00689052)
NCT ID: NCT00689052
Last Updated: 2014-06-09
Results Overview
The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)
TERMINATED
PHASE2
61 participants
Baseline and Week 29
2014-06-09
Participant Flow
Participant milestones
| Measure |
Placebo
Patients receive placebo in dose up-titration steps
|
Pramipexole
Patients receive pramipexole in dose up-titration steps
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
31
|
30
|
Reasons for withdrawal
| Measure |
Placebo
Patients receive placebo in dose up-titration steps
|
Pramipexole
Patients receive pramipexole in dose up-titration steps
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Early termination of the trial
|
22
|
24
|
Baseline Characteristics
Pramipexole ER vs. Placebo in Fibromyalgia
Baseline characteristics by cohort
| Measure |
Placebo
n=31 Participants
Patients receiving matching placebo
|
Pramipexole
n=30 Participants
Patients receiving pramipexole
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
50.7 years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
51.5 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 29 (at the end of the maintenance phase)Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
PGI-I is a self-reported scale completed by the patient that measures the degree of improvement at the time of assessment. The score ranges from 1 = very much improved to 7 = very much worse
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient . SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS). Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
11-Point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from: 0 = no pain to 10 = worst possible pain .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
FIQ is a self-reported scale completed by the patient that measures patient status, progress, and outcomes over the past week. The FIQ is composed of a total of 20 items; the first 11 items measure physical functioning, and each item is rated on a four-point Likert scale. Items 12 and 13 measure the number of days the patient felt well and the number of days the patient felt unable to work due to their fibromyalgia symptoms. Items 14 through 20 are numerical, 11-point Likert scales (marked in 10-point increments) on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
The Hospital Anxiety and Depression Scale (HADS) measures the severity of anxiety and depression. The severity score ranges from: 0 = least severe to 3 = most severe. The total score ranges from 0 to 21; the higher the score, the more severe the anxious/depressive symptoms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient . SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS). Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
The Euroqol- 5 Dimension (EQ-5D) Health Survey is a generic, multidimensional, health related, quality-of-life instrument that contains two parts-a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. The profile contains five items corresponding to five health domains- mobility, self-care, usual activities, pain/discomfort, and mood. A single score is generated for each health state. Data from the EQ-5D can be converted into 243 unique health states. For each health state, there exists a corresponding valuation that allows the patient's health to be represented as an index, which is a value between -0.594 and 1; the higher the score, the better the quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
The Multidimensional Assessment of Fatigue (MAF) Index is a 16-item, self-reporting instrument designed to collect data on four dimensions of fatigue- severity, distress, degree of interference in activities of daily living, and timing .
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
The Medical Outcomes Study (MOS) sleep scale is a 12-item (MOS1 to MOS12) self reporting sleep measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
Acetaminophen/paracetamol (maximum of 4 g/day) to be allowed as rescue medication for pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 29Population: FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS))
The Tender Point Pain Threshold will be assessed for all 18 tender points by a study clinician. A dolorimeter will be used to exert the pressure at each point and to measure the threshold reading; when the patient first indicates pain, the threshold will be recorded in kg/sq.cm ;If the patient reports pain before 1.0 kg/sq.cm is reached (\>0 kg/sq.cm), 1.0 kg/sq.cm will be entered. If the patient does not report pain when the maximum pressure is applied (10.0 kg/sq.cm),0 (no pain) will be entered.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Pramipexole
Serious adverse events
| Measure |
Placebo
n=31 participants at risk
|
Pramipexole
n=30 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
3.2%
1/31 • Up to 72 days
|
0.00%
0/30 • Up to 72 days
|
Other adverse events
| Measure |
Placebo
n=31 participants at risk
|
Pramipexole
n=30 participants at risk
|
|---|---|---|
|
Psychiatric disorders
insomnia
|
9.7%
3/31 • Up to 72 days
|
16.7%
5/30 • Up to 72 days
|
|
Psychiatric disorders
sleep attacks
|
0.00%
0/31 • Up to 72 days
|
10.0%
3/30 • Up to 72 days
|
|
Nervous system disorders
somnolence
|
3.2%
1/31 • Up to 72 days
|
16.7%
5/30 • Up to 72 days
|
|
Nervous system disorders
dizziness
|
3.2%
1/31 • Up to 72 days
|
6.7%
2/30 • Up to 72 days
|
|
Nervous system disorders
headache
|
6.5%
2/31 • Up to 72 days
|
6.7%
2/30 • Up to 72 days
|
|
Gastrointestinal disorders
nausea
|
9.7%
3/31 • Up to 72 days
|
23.3%
7/30 • Up to 72 days
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/31 • Up to 72 days
|
10.0%
3/30 • Up to 72 days
|
|
Gastrointestinal disorders
Gastrooesophageal disease
|
0.00%
0/31 • Up to 72 days
|
6.7%
2/30 • Up to 72 days
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/31 • Up to 72 days
|
6.7%
2/30 • Up to 72 days
|
|
Skin and subcutaneous tissue disorders
rash
|
6.5%
2/31 • Up to 72 days
|
0.00%
0/30 • Up to 72 days
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
9.7%
3/31 • Up to 72 days
|
3.3%
1/30 • Up to 72 days
|
|
General disorders
fatigue
|
0.00%
0/31 • Up to 72 days
|
13.3%
4/30 • Up to 72 days
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
2/31 • Up to 72 days
|
3.3%
1/30 • Up to 72 days
|
Additional Information
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER