Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.

Official Title
-----------------
Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Drug: valdecoxib
* Drug: diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain History of at least 1 reported episode of acute low back pain in the last 5 years Exclusion Criteria: History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain Moderate to severe scoliosis Back pain due to major trauma or visceral disorder Unwilling to refrain from commencing concomitant physiotherapy Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: valdecoxib<br>* valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day<br>|
| Active Comparator: Arm 2<br> | Drug: diclofenac<br>* diclofenac 75 mg twice daily (BID) for 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline |  | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient global evaluation |  | Day 3 and Day 7 | 
| Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire |  | Day 7 | 
| Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains) |  | Day 7 | 
| Pain Relief |  | Day 3 and Day 7 | 
| Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia |  | Day 7 | 
| VAS Pain Intensity (0-100 mm) |  | Day 7 | 
| Categorical Pain Intensity |  | Day 3 and Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute low back pain