Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

Phase 4

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Diclofenac; Drug: Celecoxib

• Registration Number: NCT00640432
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2004-10
• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Diclofenac	-
B	Celecoxib	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment	Day 3

Secondary Outcome Measures

Name	Time	Method
Vital signs	Days 3 and 7
Change from baseline in VAS pain intensity assessment	Day 7
Categorical pain intensity score	Days 3 and 7
Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability	Day 7
Subject's quality of life, as measured by the SF-36 Health Survey	Day 7
Physical examination	Days 3 and 7
Pain relief score	Days 3 and 7
Subject's global assessment score	Days 3 and 7
Adverse events	Days 3 and 7

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇷 São Paulo, SP, Brazil