Trial Outcomes & Findings for Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use" (NCT NCT00139776)
NCT ID: NCT00139776
Last Updated: 2021-03-29
Results Overview
Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
875 participants
Primary outcome timeframe
Period III (22 weeks)
Results posted on
2021-03-29
Participant Flow
111 centers in the Americas and Europe enrolled and treated subjects (2 centers in Belgium, 4 centers in Brazil, 20 centers in Canada, 5 centers in Chile, 5 centers in Columbia, 1 center in France, 15 centers in the United Kingdom, and 59 centers in the United States).
17 participants completed Open-label run-in Period II and were randomized to Period III Double Blind but not treated.
Participant milestones
| Measure |
Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories
Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
|
Open-Label Celecoxib Run-in Period
Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
|
Celecoxib 200mg Continuous Use
Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|---|---|
|
Period I
STARTED
|
1772
|
0
|
0
|
0
|
|
Period I
COMPLETED
|
1197
|
0
|
0
|
0
|
|
Period I
NOT COMPLETED
|
575
|
0
|
0
|
0
|
|
Period II
STARTED
|
0
|
1197
|
0
|
0
|
|
Period II
COMPLETED
|
0
|
875
|
0
|
0
|
|
Period II
NOT COMPLETED
|
0
|
322
|
0
|
0
|
|
Period III
STARTED
|
0
|
0
|
431
|
427
|
|
Period III
COMPLETED
|
0
|
0
|
355
|
321
|
|
Period III
NOT COMPLETED
|
0
|
0
|
76
|
106
|
Reasons for withdrawal
| Measure |
Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories
Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
|
Open-Label Celecoxib Run-in Period
Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
|
Celecoxib 200mg Continuous Use
Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|---|---|
|
Period I
Did not enter Period II
|
575
|
0
|
0
|
0
|
|
Period II
Not Randomized into Period III
|
0
|
322
|
0
|
0
|
|
Period III
Adverse Event
|
0
|
0
|
22
|
23
|
|
Period III
Other
|
0
|
0
|
23
|
34
|
|
Period III
Lack of Efficacy
|
0
|
0
|
10
|
24
|
|
Period III
Lost to Follow-up
|
0
|
0
|
5
|
4
|
|
Period III
Withdrawal by Subject
|
0
|
0
|
16
|
21
|
Baseline Characteristics
Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
Baseline characteristics by cohort
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
Total
n=858 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 10.00 • n=99 Participants
|
58.7 years
STANDARD_DEVIATION 9.6 • n=107 Participants
|
58.6 years
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
317 Participants
n=99 Participants
|
303 Participants
n=107 Participants
|
620 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Period III (22 weeks)Population: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication
Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Number of Flare Events Per Time of Exposure to Study Medication
|
0.54 flare events per month
Standard Deviation 0.74
|
0.93 flare events per month
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Period III (22 weeks)Population: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication.
Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Time to Occurrence of First Osteoarthritis (OA) Flare
|
16.0 days
Interval 14.0 to 22.0
|
8.0 days
Interval 8.0 to 9.0
|
SECONDARY outcome
Timeframe: Period III (22 weeks)Population: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication
Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Proportion of Days Free From Osteoarthritis (OA) Flare
|
0.77 proportion of days free from OA flare
Standard Deviation 0.28
|
0.67 proportion of days free from OA flare
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Period III (22 weeks)Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Proportion of Days in Osteoarthritis (OA) Flare
|
0.23 proportion of days in OA flare
Standard Deviation 0.28
|
0.33 proportion of days in OA flare
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Period IIIPopulation: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II.
Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Arthritis Pain Numerical Rating Scale (NRS)
Week 4 (n=415 cont; n=414 inter)
|
81.7 scores on a scale * weeks
Standard Error 1.1
|
90.5 scores on a scale * weeks
Standard Error 1.1
|
|
Arthritis Pain Numerical Rating Scale (NRS)
Week 8 (n=401 cont; n=395 inter)
|
148.8 scores on a scale * weeks
Standard Error 2.6
|
167.0 scores on a scale * weeks
Standard Error 2.6
|
|
Arthritis Pain Numerical Rating Scale (NRS)
Week 12 (n=383 cont; n=363 inter)
|
212.6 scores on a scale * weeks
Standard Error 4.1
|
234.3 scores on a scale * weeks
Standard Error 4.1
|
|
Arthritis Pain Numerical Rating Scale (NRS)
Week 16 (n=373 cont; n=339 inter)
|
272.7 scores on a scale * weeks
Standard Error 5.9
|
297.6 scores on a scale * weeks
Standard Error 5.9
|
|
Arthritis Pain Numerical Rating Scale (NRS)
Week 20 (n=362; n=323 inter)
|
335.9 scores on a scale * weeks
Standard Error 7.8
|
361.1 scores on a scale * weeks
Standard Error 7.8
|
|
Arthritis Pain Numerical Rating Scale (NRS)
Week 24 (n=350 cont; n=403 inter)
|
378.1 scores on a scale * weeks
Standard Error 9.1
|
403.9 scores on a scale * weeks
Standard Error 9.2
|
SECONDARY outcome
Timeframe: Period IIIPopulation: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. These data are presented by the weeks from the start of Period II, 2 weeks before randomization. The weeks post-randomization, Period III, are different from the study weeks i.e. includes 2 weeks from Period II.
Participant's response to question "Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today?" on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Patient's Global Assessment of Arthritis
Week 4 (n=415 cont; n=414 inter)
|
67.9 scores on a scale * weeks
Standard Error 0.68
|
71.7 scores on a scale * weeks
Standard Error 0.69
|
|
Patient's Global Assessment of Arthritis
Week 8 (n=401 cont; n=395 inter)
|
126.0 scores on a scale * weeks
Standard Error 1.55
|
133.2 scores on a scale * weeks
Standard Error 1.56
|
|
Patient's Global Assessment of Arthritis
Week 12 (n=383 cont; n=363 inter)
|
182.8 scores on a scale * weeks
Standard Error 2.48
|
188.7 scores on a scale * weeks
Standard Error 2.48
|
|
Patient's Global Assessment of Arthritis
Week 16 (n=373 cont; n=339 inter)
|
236.3 scores on a scale * weeks
Standard Error 3.59
|
241.2 scores on a scale * weeks
Standard Error 3.59
|
|
Patient's Global Assessment of Arthritis
Week 20 (n=362 cont; n=323 inter)
|
292.4 scores on a scale * weeks
Standard Error 4.83
|
293.8 scores on a scale * weeks
Standard Error 4.84
|
|
Patient's Global Assessment of Arthritis
Week 24 (n=350 cont; n=309 inter)
|
329.2 scores on a scale * weeks
Standard Error 5.75
|
328.9 scores on a scale * weeks
Standard Error 5.76
|
SECONDARY outcome
Timeframe: Period III (22 weeks)Population: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication
Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Physician's Global Assessment of Arthritis at Final Visit
Grade 1 (very good)
|
68 participants
|
39 participants
|
|
Physician's Global Assessment of Arthritis at Final Visit
Grade 2 (good)
|
242 participants
|
244 participants
|
|
Physician's Global Assessment of Arthritis at Final Visit
Grade 3 (fair)
|
91 participants
|
113 participants
|
|
Physician's Global Assessment of Arthritis at Final Visit
Grade 4 (poor)
|
23 participants
|
27 participants
|
|
Physician's Global Assessment of Arthritis at Final Visit
Grade 5 (very poor)
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Period III (22 weeks)Population: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects who did not take rescue medication were assumed to have taken 0mg and were included in the analysis. Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239.
Total amount of rescue medication (acetaminophen in milligrams \[mg\]) taken per month per participant
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Total Rescue Medication Taken (Mean)
|
1566 mg taken per month per participant
Standard Deviation 4840
|
2428 mg taken per month per participant
Standard Deviation 4974
|
SECONDARY outcome
Timeframe: Period III (22 weeks)Population: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects taking rescue medication: continuous use n=220; intermittent use n=239. Subjects who did not take rescue medication were calculated as 0 and included in the analysis.
Days on rescue medication divided by number of days on study medication in Period III
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Proportion of Days on Rescue Medication
|
0.044 proportion of days
Standard Deviation 0.102
|
0.069 proportion of days
Standard Deviation 0.121
|
SECONDARY outcome
Timeframe: Period III (22 weeks)Population: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects who did not take flare medication were calculated as 0 and included in the analysis. Number of subjects taking flare medication: continuous use n=282; intermittent use n=339.
Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Days on Flare Medication
|
6.589 days on medication per month per subject
Standard Deviation 8.589
|
9.793 days on medication per month per subject
Standard Deviation 9.253
|
SECONDARY outcome
Timeframe: Period III (22 weeks)Population: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424
Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Total WOMAC score
|
1.60 scores on a scale
Standard Error 0.71
|
4.99 scores on a scale
Standard Error 0.71
|
|
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
WOMAC pain subscale
|
0.37 scores on a scale
Standard Error 0.15
|
1.18 scores on a scale
Standard Error 0.15
|
|
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
WOMAC stiffness subscale
|
0.12 scores on a scale
Standard Error 0.07
|
0.40 scores on a scale
Standard Error 0.07
|
|
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
WOMAC physical function subscale
|
1.13 scores on a scale
Standard Error 0.51
|
3.43 scores on a scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Period III (22 weeks)Population: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Number of subjects evaluable: continuous use Period III start n=428, end n=427; intermittent use Period III start n=424, end n=424
WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Total WOMAC score
|
604.9 scores on a scale * weeks
Standard Deviation 313.10
|
693.6 scores on a scale * weeks
Standard Deviation 317.30
|
|
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
WOMAC pain subscale
|
119.2 scores on a scale * weeks
Standard Deviation 63.36
|
138.4 scores on a scale * weeks
Standard Deviation 65.95
|
|
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
WOMAC stiffness subscale
|
54.5 scores on a scale * weeks
Standard Deviation 27.57
|
62.1 scores on a scale * weeks
Standard Deviation 27.7
|
|
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
WOMAC physical function subscale
|
431.4 scores on a scale * weeks
Standard Deviation 229.38
|
493.6 scores on a scale * weeks
Standard Deviation 230.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Period IIIPopulation: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)
Subject assessment on 7 sleep associated categories. Raw scores are transformed to a 0-100 scale. Higher score indicates more of the outcome (e.g. more snoring, more adequate sleep). Score at end of Period III minus score at start of Period III.
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Change in Medical Outcomes Study Sleep Scale - All Assessments
Sleep disturbance (n=415 cont; n=410 inter)
|
0.5 scores on a scale
Standard Deviation 15.95
|
-1.4 scores on a scale
Standard Deviation 15.55
|
|
Change in Medical Outcomes Study Sleep Scale - All Assessments
Snoring (n=415 cont; n=412 inter)
|
0.9 scores on a scale
Standard Deviation 22.36
|
0.7 scores on a scale
Standard Deviation 21.73
|
|
Change in Medical Outcomes Study Sleep Scale - All Assessments
Awaken short of breath (n=417 cont; n=411 inter)
|
1.9 scores on a scale
Standard Deviation 16.14
|
1.1 scores on a scale
Standard Deviation 20.00
|
|
Change in Medical Outcomes Study Sleep Scale - All Assessments
Quantity of sleep (n=417 cont; n=413 inter)
|
-0.1 scores on a scale
Standard Deviation 0.91
|
-0.1 scores on a scale
Standard Deviation 0.89
|
|
Change in Medical Outcomes Study Sleep Scale - All Assessments
Sleep adequacy (n=416 cont; n=413 inter)
|
0.1 scores on a scale
Standard Deviation 24.47
|
-1.3 scores on a scale
Standard Deviation 22.26
|
|
Change in Medical Outcomes Study Sleep Scale - All Assessments
Somnolence (n=416 cont; n=413 inter)
|
1.4 scores on a scale
Standard Deviation 14.55
|
0.6 scores on a scale
Standard Deviation 13.70
|
|
Change in Medical Outcomes Study Sleep Scale - All Assessments
Sleep problems index I (n=416 cont; n=410 inter)
|
0.9 scores on a scale
Standard Deviation 13.20
|
0.5 scores on a scale
Standard Deviation 13.18
|
|
Change in Medical Outcomes Study Sleep Scale - All Assessments
Sleep problems index II (n=413 cont; n=408 inter)
|
0.7 scores on a scale
Standard Deviation 12.29
|
-0.1 scores on a scale
Standard Deviation 12.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Period IIIPopulation: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication
Transformed score scale: 1=optimal; 0=not optimal; mixed = both optimal and non-optimal sleep during Period III
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep
Optimal (all scores are 1)
|
139 participants
|
123 participants
|
|
Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep
Mixed (scores are both 1 and 0)
|
166 participants
|
165 participants
|
|
Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep
Not optimal (all scores are 0)
|
115 participants
|
132 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Period IIIPopulation: Intent to treat (ITT) population included subjects who were randomized and received at least one dose of double blind study medication. Subjects assessed per scale n=continuous use (cont); n=intermittent use (inter)
SF-12v2 is a 12 item health survey covering 7 topics. Raw scores are transformed to a 0 to 100 scale. Higher scores indicate better state of health. Score at end of Period III minus score at start of Period III.
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=431 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
n=427 Participants
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Role physical (n=416 cont; n=412 inter)
|
3.5 scores on a scale
Standard Deviation 19.93
|
-1.1 scores on a scale
Standard Deviation 20.07
|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Bodily pain (n=417 cont; n=414 inter)
|
3.8 scores on a scale
Standard Deviation 20.11
|
-0.3 scores on a scale
Standard Deviation 21.56
|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
General health (n=417 cont; n=414 inter)
|
-0.3 scores on a scale
Standard Deviation 17.60
|
-0.8 scores on a scale
Standard Deviation 17.27
|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Physical function (n=417 cont; n=413 inter)
|
1.8 scores on a scale
Standard Deviation 23.03
|
-3.2 scores on a scale
Standard Deviation 22.77
|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Vitality (n=416 cont; n=414 inter)
|
0.3 scores on a scale
Standard Deviation 20.43
|
-3.5 scores on a scale
Standard Deviation 18.34
|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Social functioning (n=416 cont; n=414 inter)
|
-1.9 scores on a scale
Standard Deviation 20.16
|
-3.5 scores on a scale
Standard Deviation 22.37
|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Role emotional (n=417 cont; n=413 inter)
|
-0.7 scores on a scale
Standard Deviation 18.62
|
-2.1 scores on a scale
Standard Deviation 19.80
|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Mental health (n=416 cont; n=413 inter)
|
-0.9 scores on a scale
Standard Deviation 15.57
|
-1.3 scores on a scale
Standard Deviation 16.05
|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Physical component summary(n=416 cont;n=411 inter)
|
9.0 scores on a scale
Standard Deviation 55.55
|
-5.2 scores on a scale
Standard Deviation 57.48
|
|
Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
Mental component summary (n=416 cont;n=411 inter)
|
-3.1 scores on a scale
Standard Deviation 51.59
|
-10.5 scores on a scale
Standard Deviation 55.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeks prior to double blind dosingPopulation: 1197 participants entered the open-label run-in (period II) to allow observation of successful treatment of an osteoarthritis flare. 875 participants were randomized to double blind treatment (period III). 322 participants were not randomized.
Serious adverse events occuring during the 2 week run-in period (Period II) when all participants were dosed with celecoxib 200 mg daily
Outcome measures
| Measure |
Celecoxib 200mg Continuous Use
n=1197 Participants
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Serious Adverse Events in Open Label run-in Period
Anaemia
|
1 participants
|
—
|
|
Serious Adverse Events in Open Label run-in Period
Vitreous haemorrhage
|
1 participants
|
—
|
Adverse Events
Celecoxib 200mg Continuous Use
Serious events: 6 serious events
Other events: 242 other events
Deaths: 0 deaths
Celecoxib 200mg Intermittent Use
Serious events: 10 serious events
Other events: 246 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Celecoxib 200mg Continuous Use
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.23%
1/431
|
0.00%
0/427
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Melaena
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.23%
1/431
|
0.00%
0/427
|
|
General disorders
Chest pain
|
0.23%
1/431
|
0.23%
1/427
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/431
|
0.47%
2/427
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.23%
1/431
|
0.00%
0/427
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/431
|
0.23%
1/427
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/431
|
0.23%
1/427
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/431
|
0.23%
1/427
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.23%
1/431
|
0.00%
0/427
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.23%
1/431
|
0.00%
0/427
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.23%
1/431
|
0.00%
0/427
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/431
|
0.23%
1/427
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/431
|
0.23%
1/427
|
Other adverse events
| Measure |
Celecoxib 200mg Continuous Use
Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
|
Celecoxib 200mg Intermittent Use
Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.23%
1/431
|
0.00%
0/427
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.23%
1/431
|
0.47%
2/427
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/431
|
0.00%
0/427
|
|
Cardiac disorders
Bundle branch block left
|
0.23%
1/431
|
0.00%
0/427
|
|
Cardiac disorders
Extrasystoles
|
0.23%
1/431
|
0.00%
0/427
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/431
|
0.23%
1/427
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/431
|
0.23%
1/427
|
|
Cardiac disorders
Tachycardia
|
0.23%
1/431
|
0.00%
0/427
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.23%
1/431
|
0.23%
1/427
|
|
Ear and labyrinth disorders
Deafness
|
0.23%
1/431
|
0.00%
0/427
|
|
Ear and labyrinth disorders
Ear disorder
|
0.23%
1/431
|
0.00%
0/427
|
|
Ear and labyrinth disorders
Ear pain
|
0.46%
2/431
|
0.47%
2/427
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/431
|
0.23%
1/427
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.23%
1/431
|
0.00%
0/427
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
5/431
|
0.70%
3/427
|
|
Endocrine disorders
Goitre
|
0.23%
1/431
|
0.00%
0/427
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/431
|
0.23%
1/427
|
|
Eye disorders
Cataract
|
0.00%
0/431
|
0.23%
1/427
|
|
Eye disorders
Conjunctivitis
|
0.23%
1/431
|
0.00%
0/427
|
|
Eye disorders
Conjunctivitis allergic
|
0.23%
1/431
|
0.00%
0/427
|
|
Eye disorders
Diplopia
|
0.23%
1/431
|
0.00%
0/427
|
|
Eye disorders
Dry eye
|
0.46%
2/431
|
0.00%
0/427
|
|
Eye disorders
Eye allergy
|
0.23%
1/431
|
0.00%
0/427
|
|
Eye disorders
Eye irritation
|
0.00%
0/431
|
0.23%
1/427
|
|
Eye disorders
Glaucoma
|
0.23%
1/431
|
0.00%
0/427
|
|
Eye disorders
Lacrimation increased
|
0.23%
1/431
|
0.23%
1/427
|
|
Eye disorders
Myodesopsia
|
0.00%
0/431
|
0.23%
1/427
|
|
Eye disorders
Vision blurred
|
0.46%
2/431
|
0.23%
1/427
|
|
Eye disorders
Visual acuity reduced
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.23%
1/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Abdominal distension
|
0.70%
3/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
10/431
|
0.70%
3/427
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.6%
7/431
|
2.3%
10/427
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Colitis
|
0.23%
1/431
|
0.47%
2/427
|
|
Gastrointestinal disorders
Constipation
|
1.2%
5/431
|
0.94%
4/427
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
7/431
|
4.0%
17/427
|
|
Gastrointestinal disorders
Dry mouth
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Dyspepsia
|
3.9%
17/431
|
1.4%
6/427
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Flatulence
|
0.46%
2/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
5/431
|
0.47%
2/427
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.93%
4/431
|
0.70%
3/427
|
|
Gastrointestinal disorders
Gastrooesophagitis
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Gingival pain
|
0.23%
1/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.23%
1/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.70%
3/431
|
0.70%
3/427
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Nausea
|
1.2%
5/431
|
2.1%
9/427
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.23%
1/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.93%
4/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Stomatitis
|
0.23%
1/431
|
0.00%
0/427
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/431
|
0.23%
1/427
|
|
Gastrointestinal disorders
Toothache
|
0.70%
3/431
|
1.4%
6/427
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
5/431
|
1.4%
6/427
|
|
General disorders
Asthenia
|
0.23%
1/431
|
0.00%
0/427
|
|
General disorders
Chest discomfort
|
0.23%
1/431
|
0.00%
0/427
|
|
General disorders
Chest pain
|
0.46%
2/431
|
0.94%
4/427
|
|
General disorders
Fatigue
|
1.4%
6/431
|
2.1%
9/427
|
|
General disorders
Feeling hot
|
0.00%
0/431
|
0.23%
1/427
|
|
General disorders
Gravitational oedema
|
0.00%
0/431
|
0.23%
1/427
|
|
General disorders
Hypothermia
|
0.00%
0/431
|
0.23%
1/427
|
|
General disorders
Influenza like illness
|
0.23%
1/431
|
0.94%
4/427
|
|
General disorders
Malaise
|
0.00%
0/431
|
0.23%
1/427
|
|
General disorders
Oedema peripheral
|
0.93%
4/431
|
2.8%
12/427
|
|
General disorders
Pain
|
1.4%
6/431
|
2.1%
9/427
|
|
General disorders
Pyrexia
|
0.46%
2/431
|
1.2%
5/427
|
|
General disorders
Swelling
|
0.00%
0/431
|
0.23%
1/427
|
|
General disorders
Thirst
|
0.00%
0/431
|
0.23%
1/427
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
1/431
|
0.00%
0/427
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/431
|
0.23%
1/427
|
|
Immune system disorders
Seasonal allergy
|
0.46%
2/431
|
0.23%
1/427
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
American trypanosomiasis
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Bronchitis
|
0.93%
4/431
|
2.1%
9/427
|
|
Infections and infestations
Cellulitis
|
0.46%
2/431
|
0.47%
2/427
|
|
Infections and infestations
Cystitis
|
0.23%
1/431
|
0.94%
4/427
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Ear infection
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Gastroenteritis
|
0.46%
2/431
|
0.00%
0/427
|
|
Infections and infestations
Gastroenteritis viral
|
0.23%
1/431
|
0.23%
1/427
|
|
Infections and infestations
Groin abscess
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Herpes zoster
|
0.23%
1/431
|
0.70%
3/427
|
|
Infections and infestations
Infected bites
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Influenza
|
2.3%
10/431
|
2.1%
9/427
|
|
Infections and infestations
Labyrinthitis
|
0.23%
1/431
|
0.23%
1/427
|
|
Infections and infestations
Laryngitis
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Localised infection
|
0.46%
2/431
|
0.00%
0/427
|
|
Infections and infestations
Lower respiratory tract infection
|
0.23%
1/431
|
0.23%
1/427
|
|
Infections and infestations
Lymph gland infection
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Nail infection
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Nasopharyngitis
|
4.4%
19/431
|
4.7%
20/427
|
|
Infections and infestations
Onychomycosis
|
0.23%
1/431
|
0.23%
1/427
|
|
Infections and infestations
Oral herpes
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Otitis externa
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Otitis media
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Pharyngitis
|
0.93%
4/431
|
0.70%
3/427
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Pyelonephritis
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Pyoderma
|
0.23%
1/431
|
0.23%
1/427
|
|
Infections and infestations
Rhinitis
|
0.23%
1/431
|
0.23%
1/427
|
|
Infections and infestations
Sinusitis
|
2.6%
11/431
|
2.3%
10/427
|
|
Infections and infestations
Sinusitis bacterial
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Tonsillitis
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Tooth abscess
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Tooth infection
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
14/431
|
4.4%
19/427
|
|
Infections and infestations
Urinary tract infection
|
1.6%
7/431
|
1.6%
7/427
|
|
Infections and infestations
Viral infection
|
0.70%
3/431
|
0.94%
4/427
|
|
Infections and infestations
Viral pharyngitis
|
0.23%
1/431
|
0.00%
0/427
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.23%
1/431
|
0.23%
1/427
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/431
|
0.47%
2/427
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/431
|
0.23%
1/427
|
|
Infections and infestations
Wound infection
|
0.00%
0/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.23%
1/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.23%
1/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/431
|
0.47%
2/427
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Contusion
|
0.70%
3/431
|
1.6%
7/427
|
|
Injury, poisoning and procedural complications
Device breakage
|
0.00%
0/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.93%
4/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/431
|
0.47%
2/427
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.23%
1/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
1/431
|
0.47%
2/427
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.70%
3/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.46%
2/431
|
0.47%
2/427
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.23%
1/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.23%
1/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.23%
1/431
|
0.47%
2/427
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/431
|
0.47%
2/427
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.23%
1/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.46%
2/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Repetitive strain injury
|
0.23%
1/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.23%
1/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.46%
2/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.23%
1/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/431
|
0.23%
1/427
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.23%
1/431
|
0.00%
0/427
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.23%
1/431
|
0.00%
0/427
|
|
Investigations
Alanine aminotransferase increased
|
0.23%
1/431
|
0.00%
0/427
|
|
Investigations
Aspartate aminotransferase increased
|
0.23%
1/431
|
0.00%
0/427
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/431
|
0.23%
1/427
|
|
Investigations
Blood creatinine increased
|
0.00%
0/431
|
0.47%
2/427
|
|
Investigations
Blood potassium increased
|
0.00%
0/431
|
0.23%
1/427
|
|
Investigations
Blood pressure increased
|
0.00%
0/431
|
0.94%
4/427
|
|
Investigations
Blood urea increased
|
0.00%
0/431
|
0.47%
2/427
|
|
Investigations
Blood urine present
|
0.00%
0/431
|
0.23%
1/427
|
|
Investigations
Cardiac murmur
|
0.00%
0/431
|
0.23%
1/427
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.23%
1/431
|
0.00%
0/427
|
|
Investigations
Heart rate irregular
|
0.23%
1/431
|
0.00%
0/427
|
|
Investigations
Hepatic enzyme increased
|
0.23%
1/431
|
0.00%
0/427
|
|
Investigations
Hepatitis C positive
|
0.00%
0/431
|
0.23%
1/427
|
|
Investigations
Weight increased
|
0.23%
1/431
|
0.23%
1/427
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
1/431
|
0.47%
2/427
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.23%
1/431
|
0.23%
1/427
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.23%
1/431
|
0.23%
1/427
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.23%
1/431
|
0.23%
1/427
|
|
Metabolism and nutrition disorders
Hyperlipdaemia
|
0.00%
0/431
|
0.23%
1/427
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.23%
1/431
|
0.00%
0/427
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.23%
1/431
|
0.00%
0/427
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/431
|
0.23%
1/427
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
17/431
|
5.9%
25/427
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
20/431
|
7.3%
31/427
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.70%
3/431
|
0.00%
0/427
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.4%
6/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.23%
1/431
|
0.00%
0/427
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.23%
1/431
|
0.00%
0/427
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.23%
1/431
|
0.00%
0/427
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.23%
1/431
|
0.00%
0/427
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.23%
1/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.23%
1/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.23%
1/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
10/431
|
1.2%
5/427
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
7/431
|
2.8%
12/427
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
10/431
|
2.1%
9/427
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
7/431
|
1.6%
7/427
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
7/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
18/431
|
4.9%
21/427
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/431
|
0.70%
3/427
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.23%
1/431
|
0.00%
0/427
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.23%
1/431
|
0.00%
0/427
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/431
|
0.23%
1/427
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.00%
0/431
|
0.47%
2/427
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/431
|
0.47%
2/427
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.23%
1/431
|
0.00%
0/427
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/431
|
0.23%
1/427
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/431
|
0.23%
1/427
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/431
|
0.23%
1/427
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/431
|
0.23%
1/427
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Cluster headache
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Dizziness
|
1.9%
8/431
|
1.9%
8/427
|
|
Nervous system disorders
Dysgeusia
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/431
|
0.23%
1/427
|
|
Nervous system disorders
Headache
|
15.1%
65/431
|
15.9%
68/427
|
|
Nervous system disorders
Hypoaesthesia
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Lethargy
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/431
|
0.23%
1/427
|
|
Nervous system disorders
Migraine
|
0.23%
1/431
|
0.47%
2/427
|
|
Nervous system disorders
Migraine with aura
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Neuropathy peripheral
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Paraesthesia
|
0.46%
2/431
|
0.70%
3/427
|
|
Nervous system disorders
Poor quality sleep
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/431
|
0.23%
1/427
|
|
Nervous system disorders
Sciatica
|
0.23%
1/431
|
0.47%
2/427
|
|
Nervous system disorders
Sinus headache
|
0.46%
2/431
|
0.23%
1/427
|
|
Nervous system disorders
Somnolence
|
0.23%
1/431
|
0.23%
1/427
|
|
Nervous system disorders
Syncope
|
0.23%
1/431
|
0.00%
0/427
|
|
Nervous system disorders
Tension headache
|
0.00%
0/431
|
0.23%
1/427
|
|
Nervous system disorders
Tremor
|
0.46%
2/431
|
0.23%
1/427
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/431
|
0.23%
1/427
|
|
Psychiatric disorders
Anxiety
|
0.93%
4/431
|
0.23%
1/427
|
|
Psychiatric disorders
Attention deficit / hyperactivity disorder
|
0.23%
1/431
|
0.00%
0/427
|
|
Psychiatric disorders
Confusional state
|
0.23%
1/431
|
0.00%
0/427
|
|
Psychiatric disorders
Depressed mood
|
0.23%
1/431
|
0.00%
0/427
|
|
Psychiatric disorders
Depression
|
1.2%
5/431
|
0.70%
3/427
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/431
|
0.23%
1/427
|
|
Psychiatric disorders
Insomnia
|
2.6%
11/431
|
1.9%
8/427
|
|
Psychiatric disorders
Libido decreased
|
0.46%
2/431
|
0.00%
0/427
|
|
Psychiatric disorders
Nervousness
|
0.23%
1/431
|
0.00%
0/427
|
|
Psychiatric disorders
Nightmare
|
0.23%
1/431
|
0.00%
0/427
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/431
|
0.23%
1/427
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/431
|
0.23%
1/427
|
|
Psychiatric disorders
Stress
|
0.00%
0/431
|
0.23%
1/427
|
|
Renal and urinary disorders
Dysuria
|
0.46%
2/431
|
0.00%
0/427
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/431
|
0.23%
1/427
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.23%
1/431
|
0.00%
0/427
|
|
Renal and urinary disorders
Micturition frequency decreased
|
0.00%
0/431
|
0.23%
1/427
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/431
|
0.47%
2/427
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/431
|
0.23%
1/427
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/431
|
0.47%
2/427
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/431
|
0.23%
1/427
|
|
Renal and urinary disorders
Renal pain
|
0.46%
2/431
|
0.00%
0/427
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.23%
1/431
|
0.00%
0/427
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
0.23%
1/431
|
0.00%
0/427
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/431
|
0.23%
1/427
|
|
Reproductive system and breast disorders
Breast pain
|
0.23%
1/431
|
0.00%
0/427
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.46%
2/431
|
0.94%
4/427
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.23%
1/431
|
0.23%
1/427
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/431
|
0.23%
1/427
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/431
|
0.23%
1/427
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/431
|
0.47%
2/427
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/431
|
0.23%
1/427
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.93%
4/431
|
0.47%
2/427
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/431
|
0.23%
1/427
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/431
|
0.23%
1/427
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.93%
4/431
|
0.94%
4/427
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.70%
3/431
|
0.70%
3/427
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.23%
1/431
|
0.00%
0/427
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/431
|
0.23%
1/427
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
5/431
|
0.70%
3/427
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.23%
1/431
|
0.00%
0/427
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
7/431
|
0.94%
4/427
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/431
|
0.23%
1/427
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.23%
1/431
|
0.00%
0/427
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/431
|
0.23%
1/427
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.23%
1/431
|
0.23%
1/427
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/431
|
0.23%
1/427
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.70%
3/431
|
0.47%
2/427
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.46%
2/431
|
0.00%
0/427
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.70%
3/431
|
0.47%
2/427
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/431
|
0.23%
1/427
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.46%
2/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.23%
1/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/431
|
0.70%
3/427
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/431
|
0.23%
1/427
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.23%
1/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.23%
1/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.23%
1/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.46%
2/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.23%
1/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/431
|
0.47%
2/427
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.23%
1/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/431
|
0.23%
1/427
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.70%
3/431
|
0.47%
2/427
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.23%
1/431
|
1.6%
7/427
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/431
|
0.23%
1/427
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.23%
1/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.23%
1/431
|
0.00%
0/427
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.00%
0/431
|
0.23%
1/427
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/431
|
0.23%
1/427
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/431
|
0.23%
1/427
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.23%
1/431
|
0.23%
1/427
|
|
Surgical and medical procedures
Myringoplasty
|
0.00%
0/431
|
0.23%
1/427
|
|
Surgical and medical procedures
Nail operation
|
0.00%
0/431
|
0.23%
1/427
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/431
|
0.23%
1/427
|
|
Surgical and medical procedures
Vasectomy
|
0.23%
1/431
|
0.00%
0/427
|
|
Vascular disorders
Flushing
|
0.00%
0/431
|
0.23%
1/427
|
|
Vascular disorders
Hot flush
|
0.46%
2/431
|
0.00%
0/427
|
|
Vascular disorders
Hypertension
|
2.1%
9/431
|
3.0%
13/427
|
|
Vascular disorders
Systolic hypertension
|
0.23%
1/431
|
0.00%
0/427
|
|
Vascular disorders
Varicose vein
|
0.00%
0/431
|
0.23%
1/427
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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