Phase 3
Completed N=802
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
Source: ClinicalTrials.gov NCT00662558 ↗Enrolled (actual)
802
Serious AEs
—
Results posted
Nov 2009
Primary outcomePrimary: Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) — 254; 218; 142; 178 participants — p=0.008
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain) |
254; 218; 142; 178 | 0.008 sig |
| SECONDARY Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain |
-3.38; -3.25 | 0.234 |
| SECONDARY Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS) |
-34.78; -34.27 | 0.595 |
| SECONDARY Patient's Global Assessment of Disease Activity |
108; 107; 264; 259; 3; 1 | 0.829 |
| SECONDARY Physician's Global Assessment of Disease Activity |
113; 102; 253; 258; 2; 1 | 0.470 |
| SECONDARY Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score |
-4.90; -4.45 | 0.339 |
| SECONDARY Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf) |
-2.87; -2.88; -2.84; -2.87; -2.64; -2.59 | 0.741 |
| SECONDARY Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale |
-17.91; -16.34; -7.53; -5.10; -8.61; -6.21 | 0.392 |
| SECONDARY Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores |
82; 74; 94; 70; 171; 192 | 0.196 |
| SECONDARY Change From Baseline in Work Limitations Questionnaire (WLQ) |
-11.55; -13.58; -13.68; -12.65; -11.44; -11.69 | 0.252 |
| SECONDARY Patient's Global Evaluation of Study Medication |
46; 38; 97; 83; 126; 137 | 0.614 |
| SECONDARY Patient's Satisfaction Questionnaire (With Pain Relief Scale) |
23; 22; 15; 18; 22; 19 | 0.870 |
| SECONDARY Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale) |
24; 15; 16; 22; 19; 20 | 0.545 |
| SECONDARY Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ |
213; 196; 183; 200 | 0.218 |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00662558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.