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

Phase 4

Completed

• Conditions: Low Back Pain
• Interventions: Drug: valdecoxib; Drug: diclofenac

• Registration Number: NCT00649610
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2003-05
• Status Verified: 2008-03
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-04-01
• Last Update Submitted: 2008-04-07
• Last Update Posted: 2008-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	valdecoxib	-
Arm 2	diclofenac	-

Primary Outcome Measures

Name	Time	Method
Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline	Day 3

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇻🇪 Caracas, Venezuela