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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 5, 2019

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Study Location
Instituto Ortopedico de Goiania
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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Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Double-blind, Double-dummy, Multicenter Randomized Study Of The Efficacy And The Tolerability Of Valdecoxib 40mg Vs Rofecoxib 50mg In The Symptomatic Treatment Of Patients With Ankle Sprain
Brief SummaryThe 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.
Detailed DescriptionA3471007 terminated early (30Sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by Merck & Co Inc
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intervention: Drug: valdecoxib
  • Active Comparator: Arm 2
    Intervention: Drug: rofecoxib
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 28, 2018)
45
Original Actual Enrollment  ICMJE
 (submitted: April 8, 2008)
256
Actual Study Completion Date  ICMJE October 5, 2004
Actual Primary Completion DateOctober 1, 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00657449
Other Study ID Numbers  ICMJE A3471007
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

ICMJE     Data element required by the

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

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