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

Study Overview
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Brief Summary
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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

Official Title
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A Six Week Double-Blind, Randomized, Multicenter Comparison Study Of The Analgesic Effectiveness Of Celecoxib 200 Mg BID Compared To Tramadol Hydrochloride 50 Mg QID In Subjects With Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: celecoxib
* Drug: tramadol HCL


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: celecoxib<br> | Drug: celecoxib<br>* 200 mg capsules BID for 6 weeks<br>|
| Active Comparator: tramadol<br> | Drug: tramadol HCL<br>* 50 mg capsules QID for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Week 6 or Early Termination (ET) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Week 6/ET | 
| 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. | Baseline, Week 6/ET | 
| 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. | Week 6/ET | 
| 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. | Week 6/ET | 
| 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. | Baseline, Week 6/ET | 
| 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. | Baseline, Week 6/ET | 
| 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. | Baseline, Week 6/ET | 
| 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. | Baseline, Week 6/ET | 
| 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. | Baseline, Week 6/ET | 
| 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. | Weeks 1, 3, and 6/ET | 
| Patient's Satisfaction Questionnaire (With Pain Relief Scale) | Number of subjects at varying levels of pain relief (1 = very dissatisfied to 10 = very satisfied). | Week 6/ET | 
| 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). | Week 6/ET | 
| 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). | Week 6/ET | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain