Low Back Pain
Conditions
Keywords
Chronic low back pain
Brief summary
To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6
Interventions
DRUGcelecoxib
200 mg capsules BID for 6 weeks
DRUGtramadol HCL
50 mg capsules QID for 6 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject presents with duration of chronic low back pain of \> 3 months requiring regular use of analgesics (\> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used
Exclusion criteria
* The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) | Week 6 or Early Termination (ET) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS) | Baseline, Week 6/ET | 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. |
| Patient's Global Assessment of Disease Activity | Week 6/ET | 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. |
| Physician's Global Assessment of Disease Activity | Week 6/ET | 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. |
| Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score | Baseline, Week 6/ET | 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. |
| Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Baseline, Week 6/ET | 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. |
| Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Baseline, Week 6/ET | 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. |
| Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain | Baseline, Week 6/ET | 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. |
| Change From Baseline in Work Limitations Questionnaire (WLQ) | Baseline, Week 6/ET | 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. |
| Patient's Global Evaluation of Study Medication | Weeks 1, 3, and 6/ET | Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent. |
| Patient's Satisfaction Questionnaire (With Pain Relief Scale) | Week 6/ET | Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied). |
| Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | Week 6/ET | Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied). |
| Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ | Week 6/ET | 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). |
| Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores | Baseline, Week 6/ET | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib 200 mg capsules two times a day (BID) for 6 weeks | 396 |
| Tramadol HCL 50 mg capsules four times a day (QID) for 6 weeks | 396 |
| Total | 792 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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 | Randomized But Did Not Receive Treatment | 2 | 8 |
| Overall Study | Withdrawal by Subject | 7 | 12 |
Baseline characteristics
| Characteristic | Celecoxib | Tramadol HCL | Total |
|---|---|---|---|
| Age, Customized 18 to 44 years | 164 participants | 167 participants | 331 participants |
| Age, Customized 45 to 64 years | 191 participants | 182 participants | 373 participants |
| Age, Customized > = 65 years | 41 participants | 47 participants | 88 participants |
| Sex: Female, Male Female | 237 Participants | 213 Participants | 450 Participants |
| Sex: Female, Male Male | 159 Participants | 183 Participants | 342 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 89 / — | 171 / — |
| serious Total, serious adverse events | 1 / — | 0 / — |
Outcome results
Primary
Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)
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).
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) | Responders | 254 participants |
| Celecoxib | Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) | Non-responders | 142 participants |
| Tramadol HCL | Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) | Responders | 218 participants |
| Tramadol HCL | Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) | Non-responders | 178 participants |
95% CI: [0.0255, 0.1565]
Comparison: If celecoxib 200 mg BID was found to be non-inferior to tramadol hydrochloride 50 mg QID then the second step was to test the superiority of celecoxib 200 mg BID over tramadol hydrochloride 50 mg QID using a two-sided test of proportions. Differences in proportions were tested using the General Association Test of the Cochran-Mantel-Haenszel (CMH) procedure stratified by center.p-value: 0.008Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale
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.
Time frame: Baseline, Week 6/ET
Population: ITT. Number of subjects with MOS scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | 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 |
| Celecoxib | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Snoring (n=372, 365) | -7.53 scores on a scale | Standard Error 1.31 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Somnolence (n=374, 366) | -9.63 scores on a scale | Standard Error 1.05 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Tramadol HCL | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Sleep Problem Index II (n=373, 367) | -11.82 scores on a scale | Standard Error 0.89 |
| Tramadol HCL | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Sleep Disturbance (n=374, 367) | -16.34 scores on a scale | Standard Error 1.17 |
| Tramadol HCL | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Sleep Adequacy (n=373, 367) | 9.67 scores on a scale | Standard Error 1.34 |
| Tramadol HCL | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Snoring (n=372, 365) | -5.10 scores on a scale | Standard Error 1.28 |
| Tramadol HCL | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Sleep Problem Index I (n=373, 367) | -10.54 scores on a scale | Standard Error 0.92 |
| Tramadol HCL | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Awaken Shortness of Breath, Headache (n=374, 367) | -6.21 scores on a scale | Standard Error 1.34 |
| Tramadol HCL | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Somnolence (n=374, 366) | -7.01 scores on a scale | Standard Error 1.16 |
| Tramadol HCL | Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale | Quantity of Sleep (n=373, 365) | 0.58 scores on a scale | Standard Error 0.28 |
Comparison: Sleep Disturbance. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.39295% CI: [-4.26, 1.67]ANCOVA
Comparison: Snoring. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.69195% CI: [-3.94, 2.61]ANCOVA
Comparison: Awaken Shortness of Breath or Headache. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.54995% CI: [-3.7, 1.97]ANCOVA
Comparison: Quantity of Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.33695% CI: [-0.67, 0.23]ANCOVA
Comparison: Sleep Adequacy. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.3795% CI: [-4.83, 1.8]ANCOVA
Comparison: Somnolence. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.34195% CI: [-3.9, 1.35]ANCOVA
Comparison: Sleep Problem Index I. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.60495% CI: [-2.85, 1.66]ANCOVA
Comparison: Sleep Problem Index II. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.54795% CI: [-2.92, 1.55]ANCOVA
Secondary
Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)
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.
Time frame: Baseline, Week 6/ET
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | 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 |
| Celecoxib | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Pain Interference Subscale | -2.37 scores on a scale | Standard Error 0.11 |
| Celecoxib | 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 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Pain Interference Subscale | -2.33 scores on a scale | Standard Error 0.12 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | How Much Pain Now | -2.88 scores on a scale | Standard Error 0.13 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Worst Pain in Past 24 Hours | -2.87 scores on a scale | Standard Error 0.13 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Average Pain in Past 24 Hours | -2.59 scores on a scale | Standard Error 0.13 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Pain Interfered With General Activity | -2.57 scores on a scale | Standard Error 0.13 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Pain Interfered With Mood | -2.25 scores on a scale | Standard Error 0.15 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Pain Interfered With Walking Activity | -2.36 scores on a scale | Standard Error 0.13 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Pain Interfered With Relations With Others | -1.74 scores on a scale | Standard Error 0.14 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Pain Interfered With Sleep | -2.51 scores on a scale | Standard Error 0.15 |
| Tramadol HCL | Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) | Pain Interfered With Normal Work | -2.46 scores on a scale | Standard Error 0.15 |
| Tramadol HCL | 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 0.15 |
Comparison: How Much Pain Now. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.74195% CI: [-0.36, 0.25]ANCOVA
Comparison: Worst Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.79695% CI: [-0.38, 0.29]ANCOVA
Comparison: Average Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.49295% CI: [-0.41, 0.2]ANCOVA
Comparison: Pain Interfered With General Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.89395% CI: [-0.28, 0.33]ANCOVA
Comparison: Pain Interfered With Mood. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.61895% CI: [-0.4, 0.24]ANCOVA
Comparison: Pain Interfered With Walking Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.4495% CI: [-0.19, 0.43]ANCOVA
Comparison: Pain Interfered With Relations With Others. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.80695% CI: [-0.25, 0.32]ANCOVA
Comparison: Pain Interfered With Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.73995% CI: [-0.38, 0.27]ANCOVA
Comparison: Pain Interfered With Normal Work. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.99295% CI: [-0.32, 0.33]ANCOVA
Comparison: Pain Interfered With Enjoyment of Life. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.79395% CI: [-0.28, 0.36]ANCOVA
Comparison: Pain Interference Subscale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.97395% CI: [-0.27, 0.28]ANCOVA
Secondary
Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score
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.
Time frame: Baseline, Week 6/ET
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score | -4.90 scores on a scale | Standard Error 0.26 |
| Tramadol HCL | Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score | -4.45 scores on a scale | Standard Error 0.25 |
Comparison: The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.33995% CI: [-0.95, 0.33]ANCOVA
Secondary
Change From Baseline in Severity of Chronic Low Back Pain as Measured by 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). NRS-Pain scale: Change = mean score at Week 6/ET minus mean score at Baseline.
Time frame: Baseline, Week 6/ET
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | 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 |
| Tramadol HCL | Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain | -3.25 scores on a scale | Standard Error 0.13 |
Comparison: The change from Baseline was compared between the two treatment groups using analysis of covariance (ANCOVA), with treatment and center as factors, and Baseline value as a covariate.p-value: 0.23495% CI: [-0.53, 0.13]ANCOVA
Secondary
Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)
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.
Time frame: Baseline, Week 6/ET
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS) | -34.78 mm | Standard Error 1.33 |
| Tramadol HCL | Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS) | -34.27 mm | Standard Error 1.42 |
Comparison: The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.59595% CI: [-4.39, 2.52]ANCOVA
Secondary
Change From Baseline in Work Limitations Questionnaire (WLQ)
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.
Time frame: Baseline, Week 6/ET
Population: ITT. Number of subjects with WLQ scores at Baseline and Week 6/ET: n=celecoxib, tramadol HCl.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Change From Baseline in Work Limitations Questionnaire (WLQ) | Physical Scale (n=270, 254) | -13.68 scores on a scale | Standard Error 1.52 |
| Celecoxib | Change From Baseline in Work Limitations Questionnaire (WLQ) | Mental-Interpersonal Scale (n=266, 252) | -9.06 scores on a scale | Standard Error 1.35 |
| Celecoxib | Change From Baseline in Work Limitations Questionnaire (WLQ) | Output Scale (n=256, 246) | -11.44 scores on a scale | Standard Error 1.54 |
| Celecoxib | Change From Baseline in Work Limitations Questionnaire (WLQ) | Index Scale (n=223, 220) | -3.10 scores on a scale | Standard Error 0.36 |
| Celecoxib | Change From Baseline in Work Limitations Questionnaire (WLQ) | Time Scale (n=241, 239) | -11.55 scores on a scale | Standard Error 1.65 |
| Tramadol HCL | Change From Baseline in Work Limitations Questionnaire (WLQ) | Index Scale (n=223, 220) | -3.14 scores on a scale | Standard Error 0.37 |
| Tramadol HCL | Change From Baseline in Work Limitations Questionnaire (WLQ) | Time Scale (n=241, 239) | -13.58 scores on a scale | Standard Error 1.52 |
| Tramadol HCL | Change From Baseline in Work Limitations Questionnaire (WLQ) | Physical Scale (n=270, 254) | -12.65 scores on a scale | Standard Error 1.45 |
| Tramadol HCL | Change From Baseline in Work Limitations Questionnaire (WLQ) | Output Scale (n=256, 246) | -11.69 scores on a scale | Standard Error 1.7 |
| Tramadol HCL | Change From Baseline in Work Limitations Questionnaire (WLQ) | Mental-Interpersonal Scale (n=266, 252) | -9.54 scores on a scale | Standard Error 1.51 |
Comparison: Time Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.25295% CI: [-1.56, 5.94]ANCOVA
Comparison: Physical Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.79895% CI: [-3.21, 4.17]ANCOVA
Comparison: Output Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.795% CI: [-3.03, 4.51]ANCOVA
Comparison: Mental-Interpersonal Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.90295% CI: [-3.16, 3.59]ANCOVA
Comparison: Index Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.p-value: 0.58195% CI: [-0.65, 1.16]ANCOVA
Secondary
Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ
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).
Time frame: Week 6/ET
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ | Responders | 213 participants |
| Celecoxib | Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ | Non-responders | 183 participants |
| Tramadol HCL | Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ | Responders | 196 participants |
| Tramadol HCL | Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ | Non-responders | 200 participants |
Comparison: CMH test adjusted for center was used to compare the two treatment groups.p-value: 0.218Cochran-Mantel-Haenszel
Secondary
Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores
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.
Time frame: Baseline, Week 6/ET
Population: ITT. Number of subjects with MOS Optimal sleep scale scores at Week 6/ET: celecoxib n=373, tramadol HCl n=365.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores | 0 to 1 (Improvement) | 82 participants |
| Celecoxib | Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores | 1 to 1 (No change) | 94 participants |
| Celecoxib | Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores | 0 to 0 (No change) | 171 participants |
| Celecoxib | Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores | 1 to 0 (worsening) | 26 participants |
| Tramadol HCL | Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores | 1 to 0 (worsening) | 29 participants |
| Tramadol HCL | Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores | 0 to 1 (Improvement) | 74 participants |
| Tramadol HCL | Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores | 0 to 0 (No change) | 192 participants |
| Tramadol HCL | Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores | 1 to 1 (No change) | 70 participants |
Comparison: Optimal sleep was analyzed using CMH general association test.p-value: 0.196Cochran-Mantel-Haenszel
Secondary
Patient's Global Assessment of Disease Activity
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.
Time frame: Week 6/ET
Population: ITT. Number of subjects with Patient's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=375, tramadol HCl n=367.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Patient's Global Assessment of Disease Activity | Improved | 108 participants |
| Celecoxib | Patient's Global Assessment of Disease Activity | No Change | 264 participants |
| Celecoxib | Patient's Global Assessment of Disease Activity | Worsened | 3 participants |
| Tramadol HCL | Patient's Global Assessment of Disease Activity | Improved | 107 participants |
| Tramadol HCL | Patient's Global Assessment of Disease Activity | No Change | 259 participants |
| Tramadol HCL | Patient's Global Assessment of Disease Activity | Worsened | 1 participants |
Comparison: CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.p-value: 0.829Cochran-Mantel-Haenszel
Secondary
Patient's Global Evaluation of Study Medication
Number of subjects with an overall response to study medication of poor, fair, good, very good, and excellent.
Time frame: Weeks 1, 3, and 6/ET
Population: ITT.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 1, Poor | 23 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 3, Fair | 53 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 1, Very Good | 97 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 3, Poor | 23 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 3, Excellent | 52 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 6/ET, Excellent | 91 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 1, Fair | 78 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 6/ET, Very Good | 123 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 3, Very Good | 104 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 6/ET, Good | 76 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 1, Good | 126 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 6/ET, Fair | 51 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 3, Good | 122 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 6/ET, Poor | 32 participants |
| Celecoxib | Patient's Global Evaluation of Study Medication | Week 1, Excellent | 46 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 6/ET, Poor | 44 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 1, Excellent | 38 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 1, Very Good | 83 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 1, Good | 137 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 1, Fair | 57 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 1, Poor | 18 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 3, Excellent | 41 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 3, Very Good | 97 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 3, Good | 105 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 3, Fair | 51 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 3, Poor | 14 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 6/ET, Excellent | 68 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 6/ET, Very Good | 112 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 6/ET, Good | 90 participants |
| Tramadol HCL | Patient's Global Evaluation of Study Medication | Week 6/ET, Fair | 51 participants |
Comparison: P-value reported is the overall p-value for Week 1.p-value: 0.614Cochran-Mantel-Haenszel
Comparison: P-value reported is the overall p-value for Week 3.p-value: 0.786Cochran-Mantel-Haenszel
Comparison: P-value reported is the overall p-value for Week 6/ET.p-value: 0.044Cochran-Mantel-Haenszel
Secondary
Patient's Satisfaction Questionnaire (With Pain Relief Scale)
Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).
Time frame: Week 6/ET
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 1 | 23 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 2 | 15 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 3 | 22 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 4 | 22 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 5 | 44 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 6 | 23 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 7 | 21 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 8 | 63 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 9 | 53 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 10 | 87 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 8 | 56 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 1 | 22 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 6 | 29 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 2 | 18 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 10 | 69 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 3 | 19 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 7 | 39 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 4 | 20 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 9 | 62 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Pain Relief Scale) | 5 | 30 participants |
Comparison: CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.p-value: 0.87Cochran-Mantel-Haenszel
Secondary
Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)
Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied).
Time frame: Week 6/ET
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 1 | 24 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 2 | 16 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 3 | 19 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 4 | 31 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 5 | 35 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 6 | 32 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 7 | 35 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 8 | 55 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 9 | 56 participants |
| Celecoxib | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 10 | 70 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 8 | 46 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 1 | 15 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 6 | 30 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 2 | 22 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 10 | 44 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 3 | 20 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 7 | 37 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 4 | 33 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 9 | 77 participants |
| Tramadol HCL | Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) | 5 | 40 participants |
Comparison: CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.p-value: 0.545Cochran-Mantel-Haenszel
Secondary
Physician's Global Assessment of Disease Activity
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.
Time frame: Week 6/ET
Population: ITT. Number of subjects with Physician's Global Assessment of Disease Activity scores at Week 6/ET: celecoxib n=368, tramadol HCl n=361.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Celecoxib | Physician's Global Assessment of Disease Activity | Improved | 113 participants |
| Celecoxib | Physician's Global Assessment of Disease Activity | No Change | 253 participants |
| Celecoxib | Physician's Global Assessment of Disease Activity | Worsened | 2 participants |
| Tramadol HCL | Physician's Global Assessment of Disease Activity | Improved | 102 participants |
| Tramadol HCL | Physician's Global Assessment of Disease Activity | No Change | 258 participants |
| Tramadol HCL | Physician's Global Assessment of Disease Activity | Worsened | 1 participants |
Comparison: CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.p-value: 0.47Cochran-Mantel-Haenszel