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

Low Back Pain Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of The Safety, Tolerability And Efficacy Of Celecoxib 200 Mg Twice A Day (With A 400 Mg Attack Dose) Versus Sodium Diclofenac 75 Mg Twice A Day In Subjects With Acute Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640432
• Other study ID #: A3191064
• Status: Completed
• Phase: Phase 4
• Start date: October 2003
• Est. completion date: October 2004

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Aged between 18 and 65 years

• Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (>50 mm in the VAS)

• Acute low back pain onset <72 hours prior to study inclusion and >6 weeks after the last acute low back pain episode

Exclusion criteria:

• Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain

• Low back pain from major trauma or visceral disorder

• Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Diclofenac
75 mg oral capsule twice daily for 7 days
• Celecoxib
400 mg oral capsule followed by 200 mg oral capsule with the evening meal (>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Goiânia	GO
Brazil	Pfizer Investigational Site	Goiânia	GO
Brazil	Pfizer Investigational Site	Goiânia	GO
Brazil	Pfizer Investigational Site	Londrina	PR
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Salvador	BA
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment		Day 3
Secondary	Subject's quality of life, as measured by the SF-36 Health Survey		Day 7
Secondary	Physical examination		Days 3 and 7
Secondary	Pain relief score		Days 3 and 7
Secondary	Vital signs		Days 3 and 7
Secondary	Adverse events		Days 3 and 7
Secondary	Change from baseline in VAS pain intensity assessment		Day 7
Secondary	Categorical pain intensity score		Days 3 and 7
Secondary	Subject's global assessment score		Days 3 and 7
Secondary	Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability		Day 7

External Links

•   To obtain contact information for a study center near you, click here.