Back to resultsA 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
Primary Purpose
Acute Pain
Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
valdecoxib
rofecoxib
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring sprains and strains
Eligibility Criteria
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
Sites / Locations
- Instituto Ortopedico de Goiania
- Centro de Traumatologia e Ortopedia
- Hospital Mãe de Deus
- Hospital Sao Zacarias
- Grupo Hospitalar Conceiçao
- Hospital Geral do Grajau
- Unifesp - Hsp
- SECONCI
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
change from baseline in visual analogue scale (VAS) pain intensity
Secondary Outcome Measures
patient's assessment of ankle pain VAS (0-100 mm)
patient's and physician's global assessment of ankle injury
patient's and physician's satisfaction assessments
patient's assessment of normal function/activity
adverse events, physical examinations, and baseline clinical laboratory values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00657449
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
June 4, 2003 (Actual)
Primary Completion Date
October 1, 2004 (Actual)
Study Completion Date
October 5, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
A3471007 terminated early (30Sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by Merck & Co Inc
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
sprains and strains
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Intervention Description
valdecoxib 80 mg (two 40 mg tablets) by mouth on Day 1 and valdecoxib 40 mg tablet once daily on Days 2-8
Intervention Type
Drug
Intervention Name(s)
rofecoxib
Intervention Description
rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days
Primary Outcome Measure Information:
Title
change from baseline in visual analogue scale (VAS) pain intensity
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
patient's assessment of ankle pain VAS (0-100 mm)
Time Frame
Days 1, 4 and 8
Title
patient's and physician's global assessment of ankle injury
Time Frame
Days 1, 4 and 8
Title
patient's and physician's satisfaction assessments
Time Frame
Day 8
Title
patient's assessment of normal function/activity
Time Frame
Days 1, 4 and 8
Title
adverse events, physical examinations, and baseline clinical laboratory values
Time Frame
Adverse Events: Days 1, 4 and 8; Physical examinations: days 1 and 8; Lab tests: day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Ortopedico de Goiania
City
Goiania
State/Province
Goias
ZIP/Postal Code
74210-030
Country
Brazil
Facility Name
Centro de Traumatologia e Ortopedia
City
Goiania
State/Province
Goiás
Country
Brazil
Facility Name
Hospital Mãe de Deus
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90880480
Country
Brazil
Facility Name
Hospital Sao Zacarias
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
Facility Name
Grupo Hospitalar Conceiçao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350200
Country
Brazil
Facility Name
Hospital Geral do Grajau
City
São Paulo
State/Province
SP
ZIP/Postal Code
04822-320
Country
Brazil
Facility Name
Unifesp - Hsp
City
São Paulo
ZIP/Postal Code
04063003
Country
Brazil
Facility Name
SECONCI
City
São Paulo
ZIP/Postal Code
05001000
Country
Brazil
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3471007&StudyName=A%20Double-blind%2C%20Double-dummy%2C%20Multicenter%20Randomized%20Study%20Of%20The%20Efficacy%20And%20The%20Tolerability%20Of%20Valdecoxib%2040mg%20Vs%20Rofecoxib%2050mg%20In%20The%20Symptomatic%20Treatment%20Of%20Patients%20With%20Ankle%20Sprain
Description
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Learn more about this trial
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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