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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

75 mg oral capsule twice daily for 7 days

B

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

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

Interventions

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Diclofenac

75 mg oral capsule twice daily for 7 days

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No