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

April 7, 2008 updated by: Pfizer

Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bs. As., Argentina
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1221ACI
        • Pfizer Investigational Site
  • Brazil
      • Sao Paulo, Brazil, 05001-000
        • Pfizer Investigational Site
    • Goias
      • Goiania, Goias, Brazil, 74085-450
        • Pfizer Investigational Site
    • PR
      • Curitiba, PR, Brazil
        • Pfizer Investigational Site
    • Parana
      • Curitiba, Parana, Brazil, 80430-210
        • Pfizer Investigational Site
    • Rio de Janeiro
      • Petropolis, Rio de Janeiro, Brazil, 25620-040
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 04029-000
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 05403-012
        • Pfizer Investigational Site
  • Chile
      • Santiago, Chile
        • Pfizer Investigational Site
  • Colombia
      • Bogota D.c, Colombia
        • Pfizer Investigational Site
      • Cali-valle, Colombia
        • Pfizer Investigational Site
    • D.c.
      • Bogota, D.c., Colombia
        • Pfizer Investigational Site
  • Costa Rica
    • Cartago
      • Cartago City, Cartago, Costa Rica, 7051
        • Pfizer Investigational Site
    • San Jose
      • Hatillo, San Jose, Costa Rica, 476-1002
        • Pfizer Investigational Site
  • Ecuador
    • Pichincha
      • Quito, Pichincha, Ecuador
        • Pfizer Investigational Site
  • Mexico
      • Puebla, Mexico, 72000
        • Pfizer Investigational Site
      • Puebla, Mexico, 72070
        • Pfizer Investigational Site
      • Puebla, Mexico, 72410
        • Pfizer Investigational Site
    • Edo. de Mexico
      • Toluca, Edo. de Mexico, Mexico, 50080
        • Pfizer Investigational Site
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45040
        • Pfizer Investigational Site
      • Zapopan, Jalisco, Mexico, 45200
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, Lima 27
        • Pfizer Investigational Site
      • Lima, Peru, LIMA 11
        • Pfizer Investigational Site
  • Venezuela
      • Caracas, Venezuela
        • Pfizer Investigational Site
    • DF
      • Caracas, DF, Venezuela, 1020
        • Pfizer Investigational Site
      • Caracas, DF, Venezuela, 1051
        • Pfizer Investigational Site
      • Caracas, DF, Venezuela, 1070
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: diclofenac
diclofenac 75 mg twice daily (BID) for 7 days
Active Comparator: Arm 1
Drug: valdecoxib
valdecoxib 40 mg QD for 7 days with a second dose of 40 mg the first day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline
Time Frame: Day 3
Day 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Categorical Pain Intensity
Time Frame: Day 3 and Day 7
Day 3 and Day 7
Patient global evaluation
Time Frame: Day 3 and Day 7
Day 3 and Day 7
Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire
Time Frame: Day 7
Day 7
Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)
Time Frame: Day 7
Day 7
Pain Relief
Time Frame: Day 3 and Day 7
Day 3 and Day 7
Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia
Time Frame: Day 7
Day 7
VAS Pain Intensity (0-100 mm)
Time Frame: Day 7
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 7, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3471012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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