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A Double-Blind, Double-Dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Goiania, Goias, 74210-030 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients had sustained, no more than 48 hours prior to the first dose of study
medication, a first- or second-degree ankle sprain of the lateral ligament,
specifically: anterior talofibular ligament and/or posterior talofibular ligament
and/or calcaneofibular ligament

- At presentation, all patients were to have Patient's Assessment of Ankle Pain Visual
Analog Scale (VAS) (0-100mm) of ≥45 mm in the orthostatic position on full weight
bearing (ie, moderate to severe pain), had a minimum rating of 2 on the Patient's
Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity

- Tthe investigator opinion was that each patient required, and was eligible for,
therapy with an anti-inflammatory agent and/or analgesics to control symptoms

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

None reported

NCT00657449
Pfizer
Terminated
A Double-Blind, Double-Dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

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A Double-Blind, Double-Dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain
A Double-Blind, Double-Dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg vs. Rofecoxib 50 mg in the Symptomatic Treatment of Patients With Ankle Sprain
The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated the disability status, tolerability and safety of these treatments.
This study was terminated early on 30 September 2004 due to safety concerns around the continued usage of rofecoxib following the withdrawal of rofecoxib from worldwide markets by Merck & Co Inc.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Acute Pain
  • Drug: valdecoxib
    valdecoxib 80 mg (two 40 mg tablets) by mouth on Day 1 and valdecoxib 40 mg tablet once daily on Days 2-8
  • Drug: rofecoxib
    rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: rofecoxib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
256
October 2004
October 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients had sustained, no more than 48 hours prior to the first dose of study medication, a first- or second-degree ankle sprain of the lateral ligament, specifically: anterior talofibular ligament and/or posterior talofibular ligament and/or calcaneofibular ligament
  • At presentation, all patients were to have Patient's Assessment of Ankle Pain Visual Analog Scale (VAS) (0-100mm) of ?45 mm in the orthostatic position on full weight bearing (ie, moderate to severe pain), had a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
  • Tthe investigator opinion was that each patient required, and was eligible for, therapy with an anti-inflammatory agent and/or analgesics to control symptoms

Exclusion Criteria:

None reported

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00657449
A3471007
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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