Trial Outcomes & Findings for A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain (NCT NCT00662558)
NCT ID: NCT00662558
Last Updated: 2021-02-21
Results Overview
A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).
COMPLETED
PHASE3
802 participants
Week 6 or Early Termination (ET)
2021-02-21
Participant Flow
Participant milestones
| Measure |
Celecoxib
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
398
|
404
|
|
Overall Study
Received Treatment
|
396
|
396
|
|
Overall Study
COMPLETED
|
342
|
294
|
|
Overall Study
NOT COMPLETED
|
56
|
110
|
Reasons for withdrawal
| Measure |
Celecoxib
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
21
|
59
|
|
Overall Study
Lack of Efficacy
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
13
|
10
|
|
Overall Study
Other
|
9
|
14
|
|
Overall Study
Withdrawal by Subject
|
7
|
12
|
|
Overall Study
Randomized But Did Not Receive Treatment
|
2
|
8
|
Baseline Characteristics
A Six Week Study Of The Pain Relieving Effects Of Celecoxib 200 Mg Twice Daily Compared To Tramadol 50 Mg Four Times Daily In Patients With Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
Total
n=792 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 44 years
|
164 participants
n=5 Participants
|
167 participants
n=7 Participants
|
331 participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
191 participants
n=5 Participants
|
182 participants
n=7 Participants
|
373 participants
n=5 Participants
|
|
Age, Customized
> = 65 years
|
41 participants
n=5 Participants
|
47 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
237 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
159 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6 or Early Termination (ET)Population: Intent-to-treat = all subjects who were randomized and received at least one dose of study medication. Missing values were imputed using last observation carried forward (LOCF).
A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)
Non-responders
|
142 participants
|
178 participants
|
|
Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)
Responders
|
254 participants
|
218 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6/ETPopulation: ITT. Missing values were imputed by LOCF. Number of subjects with NRS-Pain scale scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.
NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 6/ET minus mean score at Baseline.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain
|
-3.38 scores on a scale
Standard Error 0.12
|
-3.25 scores on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline, Week 6/ETPopulation: ITT. Missing values were imputed by LOCF. Number of subjects with VAS scores at Baseline and Week 6/ET: celecoxib n=386, tramadol HCl n=385.
VAS was a 100 millimeter (mm) scale that subjects used to assess the severity of their lower back pain. Based on the following question, "During the past day, how much back pain did you have?", the subject was instructed to place a vertical line on the VAS to indicate the magnitude of his/her lower back pain. 0 mm = no pain and 100 mm = worst possible pain. VAS: Change = mean score at Week 6/ET minus mean score at Baseline.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)
|
-34.78 mm
Standard Error 1.33
|
-34.27 mm
Standard Error 1.42
|
SECONDARY outcome
Timeframe: Week 6/ETPopulation: ITT. Number of subjects with Patient's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=375, tramadol HCl n=367.
Number of subjects with a graded level of disease activity using the Patient's Global Assessment of Disease Activity 5-point scale (1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as "Improved" if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as "Worsened" if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as "No Change" otherwise.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Patient's Global Assessment of Disease Activity
No Change
|
264 participants
|
259 participants
|
|
Patient's Global Assessment of Disease Activity
Improved
|
108 participants
|
107 participants
|
|
Patient's Global Assessment of Disease Activity
Worsened
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 6/ETPopulation: ITT. Number of subjects with Physician's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=368, tramadol HCl n=361.
Number of subjects with a physician's grading of disease activity using the Physician's Global Assessment of Disease Activity 5-point scale ((1=very good, 2=good, 3=fair, 4=poor, and 5=very poor). Subjects were classified as "Improved" if their assessment reduced at least 2 grades from baseline or if their assessment changed to Grade 1 (Very Good). Subjects were classified as "Worsened" if their assessment increased at least 2 grades from baseline or if their assessment changed to Grade 5 (Very Poor). Subjects were classified as "No Change" otherwise.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Physician's Global Assessment of Disease Activity
Improved
|
113 participants
|
102 participants
|
|
Physician's Global Assessment of Disease Activity
No Change
|
253 participants
|
258 participants
|
|
Physician's Global Assessment of Disease Activity
Worsened
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6/ETPopulation: ITT. Missing values were imputed by LOCF. Number of subjects with Roland-Morris Disability total scores at Baseline and Week 6/ET= celecoxib n=391, tramadol n=389.
Each subject assessed his/her own disability due to low back pain using the RMDQ worksheet, which consisted of 24 statements of disability. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total scores could have ranged from 0 to 24, with higher scores indicating greater disability. RMDQ: Change = mean score at Week 6/ET minus mean score at Baseline.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score
|
-4.90 scores on a scale
Standard Error 0.26
|
-4.45 scores on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Baseline, Week 6/ETPopulation: ITT. Missing values were imputed by LOCF. Number of subjects with m-BPI-sf scores at Baseline and Week 6/ET: celecoxib n=373, tramadol HCl n=367.
m-BPI-sf scale assessed pain severity (0 = no pain to 10 = worst possible pain), and pain interference of functional activities (0 = does not interfere to 10 = completely interferes) during the 24 hour follow-up period. Subjects indicated: how much pain now; worst pain; average level of pain; how much pain interfered with general activity, mood, walking ability, relations with other people, sleep, normal work (including housework), and enjoyment of life. m-BPI-sf: Change = mean score at Week 6/ET minus mean score at Baseline.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Average Pain in Past 24 Hours
|
-2.64 scores on a scale
Standard Error 0.11
|
-2.59 scores on a scale
Standard Error 0.13
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Pain Interfered With General Activity
|
-2.62 scores on a scale
Standard Error 0.12
|
-2.57 scores on a scale
Standard Error 0.13
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Pain Interfered With Mood
|
-2.38 scores on a scale
Standard Error 0.14
|
-2.25 scores on a scale
Standard Error 0.15
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Pain Interfered With Walking Activity
|
-2.26 scores on a scale
Standard Error 0.13
|
-2.36 scores on a scale
Standard Error 0.13
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Pain Interfered With Sleep
|
-2.52 scores on a scale
Standard Error 0.13
|
-2.51 scores on a scale
Standard Error 0.15
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Pain Interfered With Normal Work
|
-2.57 scores on a scale
Standard Error 0.13
|
-2.46 scores on a scale
Standard Error 0.15
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Pain Interfered With Enjoyment of Life
|
-2.43 scores on a scale
Standard Error 0.14
|
-2.43 scores on a scale
Standard Error 0.15
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Pain Interference Subscale
|
-2.37 scores on a scale
Standard Error 0.11
|
-2.33 scores on a scale
Standard Error 0.12
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
How Much Pain Now
|
-2.87 scores on a scale
Standard Error 0.12
|
-2.88 scores on a scale
Standard Error 0.13
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Worst Pain in Past 24 Hours
|
-2.84 scores on a scale
Standard Error 0.13
|
-2.87 scores on a scale
Standard Error 0.13
|
|
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
Pain Interfered With Relations With Others
|
-1.79 scores on a scale
Standard Error 0.13
|
-1.74 scores on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, Week 6/ETPopulation: ITT. Number of subjects with MOS scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.
MOS sleep scale included the following attributes: sleep disturbance, snoring, awaken shortness of breath or headache, quantity of sleep, sleep adequacy, somnolence, Sleep Problem Index I, and Sleep Problem Index II. Score ranged from 0-100, with a higher score indicating more of the scale attribute (e.g., more sleep disturbance, etc.). A negative change indicated subject improvement. MOS sleep scale: Change = mean score at Week 6/ET minus mean score at Baseline.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
Sleep Disturbance (n=374, 367)
|
-17.91 scores on a scale
Standard Error 1.23
|
-16.34 scores on a scale
Standard Error 1.17
|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
Awaken Shortness of Breath, Headache (n=374, 367)
|
-8.61 scores on a scale
Standard Error 1.27
|
-6.21 scores on a scale
Standard Error 1.34
|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
Quantity of Sleep (n=373, 365)
|
0.00 scores on a scale
Standard Error 0.23
|
0.58 scores on a scale
Standard Error 0.28
|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
Sleep Adequacy (n=373, 367)
|
7.32 scores on a scale
Standard Error 1.48
|
9.67 scores on a scale
Standard Error 1.34
|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
Somnolence (n=374, 366)
|
-9.63 scores on a scale
Standard Error 1.05
|
-7.01 scores on a scale
Standard Error 1.16
|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
Sleep Problem Index I (n=373, 367)
|
-11.59 scores on a scale
Standard Error 0.96
|
-10.54 scores on a scale
Standard Error 0.92
|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
Sleep Problem Index II (n=373, 367)
|
-12.97 scores on a scale
Standard Error 0.94
|
-11.82 scores on a scale
Standard Error 0.89
|
|
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
Snoring (n=372, 365)
|
-7.53 scores on a scale
Standard Error 1.31
|
-5.10 scores on a scale
Standard Error 1.28
|
SECONDARY outcome
Timeframe: Baseline, Week 6/ETPopulation: ITT. Number of subjects with MOS Optimal sleep scale scores at Week 6/ET: celecoxib n=373, tramadol HCl n=365.
The Optimal Scale is scaled from 0 or 1 with 1 indicating 7 or 8 hours of sleep per night and 0 otherwise. Number of subjects with change of improvement (0 to 1), no change (1 to 1 or 0 to 0), or worsening (1 to 0) from baseline as indicated by the MOS Optimal sleep scale.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores
1 to 0 (worsening)
|
26 participants
|
29 participants
|
|
Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores
0 to 1 (Improvement)
|
82 participants
|
74 participants
|
|
Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores
1 to 1 (No change)
|
94 participants
|
70 participants
|
|
Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores
0 to 0 (No change)
|
171 participants
|
192 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6/ETPopulation: ITT. Number of subjects with WLQ scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.
The WLQ included the following: Time Scale, Physical Scale, Output Scale, Mental-Interpersonal Scale, and Index Scale. The scales ranged from 0 (Limited none of the time) to 100 (Limited all of the time). A negative change indicated subject improvement.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Change From Baseline in Work Limitations Questionnaire (WLQ)
Time Scale (n=241, 239)
|
-11.55 scores on a scale
Standard Error 1.65
|
-13.58 scores on a scale
Standard Error 1.52
|
|
Change From Baseline in Work Limitations Questionnaire (WLQ)
Physical Scale (n=270, 254)
|
-13.68 scores on a scale
Standard Error 1.52
|
-12.65 scores on a scale
Standard Error 1.45
|
|
Change From Baseline in Work Limitations Questionnaire (WLQ)
Index Scale (n=223, 220)
|
-3.10 scores on a scale
Standard Error 0.36
|
-3.14 scores on a scale
Standard Error 0.37
|
|
Change From Baseline in Work Limitations Questionnaire (WLQ)
Output Scale (n=256, 246)
|
-11.44 scores on a scale
Standard Error 1.54
|
-11.69 scores on a scale
Standard Error 1.70
|
|
Change From Baseline in Work Limitations Questionnaire (WLQ)
Mental-Interpersonal Scale (n=266, 252)
|
-9.06 scores on a scale
Standard Error 1.35
|
-9.54 scores on a scale
Standard Error 1.51
|
SECONDARY outcome
Timeframe: Weeks 1, 3, and 6/ETPopulation: ITT.
Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent.
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Patient's Global Evaluation of Study Medication
Week 3, Excellent
|
52 participants
|
41 participants
|
|
Patient's Global Evaluation of Study Medication
Week 3, Very Good
|
104 participants
|
97 participants
|
|
Patient's Global Evaluation of Study Medication
Week 3, Good
|
122 participants
|
105 participants
|
|
Patient's Global Evaluation of Study Medication
Week 1, Excellent
|
46 participants
|
38 participants
|
|
Patient's Global Evaluation of Study Medication
Week 1, Very Good
|
97 participants
|
83 participants
|
|
Patient's Global Evaluation of Study Medication
Week 1, Good
|
126 participants
|
137 participants
|
|
Patient's Global Evaluation of Study Medication
Week 1, Fair
|
78 participants
|
57 participants
|
|
Patient's Global Evaluation of Study Medication
Week 1, Poor
|
23 participants
|
18 participants
|
|
Patient's Global Evaluation of Study Medication
Week 3, Fair
|
53 participants
|
51 participants
|
|
Patient's Global Evaluation of Study Medication
Week 3, Poor
|
23 participants
|
14 participants
|
|
Patient's Global Evaluation of Study Medication
Week 6/ET, Excellent
|
91 participants
|
68 participants
|
|
Patient's Global Evaluation of Study Medication
Week 6/ET, Very Good
|
123 participants
|
112 participants
|
|
Patient's Global Evaluation of Study Medication
Week 6/ET, Good
|
76 participants
|
90 participants
|
|
Patient's Global Evaluation of Study Medication
Week 6/ET, Fair
|
51 participants
|
51 participants
|
|
Patient's Global Evaluation of Study Medication
Week 6/ET, Poor
|
32 participants
|
44 participants
|
SECONDARY outcome
Timeframe: Week 6/ETPopulation: ITT. Number of subjects with Patient's Satisfaction Questionnaire (with pain relief scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.
Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
2
|
15 participants
|
18 participants
|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
3
|
22 participants
|
19 participants
|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
4
|
22 participants
|
20 participants
|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
5
|
44 participants
|
30 participants
|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
6
|
23 participants
|
29 participants
|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
1
|
23 participants
|
22 participants
|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
7
|
21 participants
|
39 participants
|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
8
|
63 participants
|
56 participants
|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
9
|
53 participants
|
62 participants
|
|
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
10
|
87 participants
|
69 participants
|
SECONDARY outcome
Timeframe: Week 6/ETPopulation: ITT. Number of subjects with Patient's Satisfaction Questionnaire (with walking and bending ability scale) scores at Week 6/ET: celecoxib n=373, tramadol HCl n=364.
Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
2
|
16 participants
|
22 participants
|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
3
|
19 participants
|
20 participants
|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
8
|
55 participants
|
46 participants
|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
9
|
56 participants
|
77 participants
|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
10
|
70 participants
|
44 participants
|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
1
|
24 participants
|
15 participants
|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
4
|
31 participants
|
33 participants
|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
5
|
35 participants
|
40 participants
|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
6
|
32 participants
|
30 participants
|
|
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
7
|
35 participants
|
37 participants
|
SECONDARY outcome
Timeframe: Week 6/ETPopulation: ITT
Subjects were successful responders if they had: \> = 30% improvement from baseline to final visit in VAS assessment (as identified by 100 millimeter scale); \> = 30% improvement from baseline to final visit in Patient's Global assessment (classified as improved if assessment reduced at least 2 grades from baseline or if assessment changed to Grade 1, worsened if assessment increased at least 2 grades from baseline or if assessment changed to Grade 5, or no change; and \< 20% worsening from baseline to final visit in RMDQ assessment (lower scores indicated greater disability).
Outcome measures
| Measure |
Celecoxib
n=396 Participants
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
n=396 Participants
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ
Responders
|
213 participants
|
196 participants
|
|
Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ
Non-responders
|
183 participants
|
200 participants
|
Adverse Events
Celecoxib
Tramadol HCL
Serious adverse events
| Measure |
Celecoxib
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Surgical and medical procedures
Coronary artery bypass
|
0.25%
1/396
|
0.00%
0/396
|
Other adverse events
| Measure |
Celecoxib
200 mg capsules two times a day (BID) for 6 weeks
|
Tramadol HCL
50 mg capsules four times a day (QID) for 6 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.0%
8/396
|
6.3%
25/396
|
|
Gastrointestinal disorders
Dry mouth
|
1.5%
6/396
|
5.1%
20/396
|
|
Gastrointestinal disorders
Nausea
|
7.8%
31/396
|
17.7%
70/396
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
5/396
|
7.1%
28/396
|
|
Nervous system disorders
Dizziness
|
4.8%
19/396
|
13.4%
53/396
|
|
Nervous system disorders
Headache
|
10.4%
41/396
|
13.6%
54/396
|
|
Nervous system disorders
Somnolence
|
5.1%
20/396
|
11.1%
44/396
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.51%
2/396
|
5.8%
23/396
|
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