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

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

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-05-31

Brief Summary

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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

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Conditions

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Low Back Pain

Keywords

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acute low back pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

valdecoxib

Intervention Type DRUG

valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day

Arm 2

Group Type ACTIVE_COMPARATOR

diclofenac

Intervention Type DRUG

diclofenac 75 mg twice daily (BID) for 7 days

Interventions

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valdecoxib

valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day

Intervention Type DRUG

diclofenac

diclofenac 75 mg twice daily (BID) for 7 days

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

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Argentina Brazil Chile Colombia Costa Rica Ecuador Mexico Peru Venezuela

Other Identifiers

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A3471012

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Arm 1

valdecoxib

Arm 2

diclofenac

Interventions

valdecoxib

diclofenac

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pfizer

Responsible Party

Principal Investigators

Pfizer CT.gov Call Center

Locations

Pfizer Investigational Site

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Countries

Related Links

Other Identifiers

A3471012