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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00640432

Collaborator

(none)

244

Enrollment

Locations

Arms

Duration (Months)

27.1

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Drug: Diclofenac Drug: Celecoxib	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

244 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2003

Actual Study Completion Date :

Oct 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A	Drug: Diclofenac 75 mg oral capsule twice daily for 7 days
Experimental: B	Drug: 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

Arm

Intervention/Treatment

Active Comparator: A

Drug: Diclofenac

75 mg oral capsule twice daily for 7 days

Experimental: B

Drug: 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

Outcome Measures

Primary Outcome Measures

Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment [Day 3]

Secondary Outcome Measures

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]
Vital signs [Days 3 and 7]
Adverse events [Days 3 and 7]
Change from baseline in VAS pain intensity assessment [Day 7]
Categorical pain intensity score [Days 3 and 7]
Subject's global assessment score [Days 3 and 7]
Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability [Day 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Salvador	BA	Brazil	40420-000
2	Pfizer Investigational Site	Goiânia	GO	Brazil	74043-110
3	Pfizer Investigational Site	Goiânia	GO	Brazil	74075-020
4	Pfizer Investigational Site	Goiânia	GO	Brazil	74605-050
5	Pfizer Investigational Site	Londrina	PR	Brazil	86010-010
6	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	21215-020
7	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	21941-590
8	Pfizer Investigational Site	São Paulo	SP	Brazil	04039-004
9	Pfizer Investigational Site	São Paulo	SP	Brazil	08270-070