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A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle

Primary Purpose

Pain, Sprains and Strains, Sprain

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
valdecoxib
diclofenac
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring acute ankle sprain, acute pain, South America

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients had sprained their ankle within 48 hours
  • The sprain was a first or second degree ankle sprain of the lateral aspect, specifically: anterior talofibular ligament and/or calcaneofibular ligament
  • At presentation patients were to have had moderate-severe ankle pain, (i.e., patient's assessment of ankle pain, on full weight bearing, using a 100 mm visual analog scale (VAS) was ≥ 45 mm), have a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
  • Investigator must have thought that the patient required and was eligible for therapy with an anti-inflammatory agent and/or analgesic to control symptoms

Exclusion Criteria:

  • Women who were not post-menopausal or surgically sterilized, or who had have a positive urine pregnancy test prior to randomization and/or were not using adequate contraception according to the judgment of the Investigator
  • Patients with a similar injury of the same joint within the last 6 months
  • Clinical evidence of complete rupture of ankle ligaments (third degree sprain), required bed rest, hospitalization, surgical intervention for the ankle injury or non-removable full cast, bilateral occurrence of ankle injury or ankle and knee injury on the same side
  • Patients with esophageal, gastric or duodenal ulcer within 30 days prior to randomization or had active GI or other disease that in the opinion of the investigator would preclude safe participation by the subject in the study.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

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

Patient's assessment of ankle pain VAS

Secondary Outcome Measures

Time to onset of pain relief
Physician's global assessment of ankle injury
Patient's global assessment of ankle injury
Patient's assessment of normal function/activity
Patient's and physician's satisfaction assessments
Patient's assessment of ankle pain on visual analogue scale (VAS)

Full Information

First Posted
March 31, 2008
Last Updated
April 30, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00671320
Brief Title
A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle
Official Title
A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib Vs. Diclofenac In Ankle Sprain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Sprains and Strains, Sprain
Keywords
acute ankle sprain, acute pain, South America

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (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 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days
Primary Outcome Measure Information:
Title
Patient's assessment of ankle pain VAS
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Time to onset of pain relief
Time Frame
0, 15, 30, 45, and 60 minutes after first dose
Title
Physician's global assessment of ankle injury
Time Frame
Days 1, 4, and 7
Title
Patient's global assessment of ankle injury
Time Frame
Days 1, 4 and 7
Title
Patient's assessment of normal function/activity
Time Frame
Days 1 to 7
Title
Patient's and physician's satisfaction assessments
Time Frame
Day 7
Title
Patient's assessment of ankle pain on visual analogue scale (VAS)
Time Frame
Days 1 to 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients had sprained their ankle within 48 hours The sprain was a first or second degree ankle sprain of the lateral aspect, specifically: anterior talofibular ligament and/or calcaneofibular ligament At presentation patients were to have had moderate-severe ankle pain, (i.e., patient's assessment of ankle pain, on full weight bearing, using a 100 mm visual analog scale (VAS) was ≥ 45 mm), have a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity Investigator must have thought that the patient required and was eligible for therapy with an anti-inflammatory agent and/or analgesic to control symptoms Exclusion Criteria: Women who were not post-menopausal or surgically sterilized, or who had have a positive urine pregnancy test prior to randomization and/or were not using adequate contraception according to the judgment of the Investigator Patients with a similar injury of the same joint within the last 6 months Clinical evidence of complete rupture of ankle ligaments (third degree sprain), required bed rest, hospitalization, surgical intervention for the ankle injury or non-removable full cast, bilateral occurrence of ankle injury or ankle and knee injury on the same side Patients with esophageal, gastric or duodenal ulcer within 30 days prior to randomization or had active GI or other disease that in the opinion of the investigator would preclude safe participation by the subject in the study.
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
Pfizer Investigational Site
City
Avellaneda
State/Province
Buenos Aires
ZIP/Postal Code
1872
Country
Argentina
Facility Name
Pfizer Investigational Site
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
Country
Chile
Facility Name
Pfizer Investigational Site
City
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
(574) 5141516
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
(57) 310-2322198
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
(57) 310-8849622
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinarmarca
ZIP/Postal Code
(571) 6 164278
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
(577) 6 395409
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cali
State/Province
Valle del Cauca
ZIP/Postal Code
(57) 315-5410469
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Calli
State/Province
Valle del Cauca
ZIP/Postal Code
(57) 310-8259712
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
Country
Peru

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=VALA-0513-146&StudyName=A%20Multi-Center%2C%20Randomized%2C%20Double-Blind%2C%20Parallel%20Group%20Study%20To%20Compare%20The%20Efficacy%20And%20Tolerability%20Of%20Valdecoxib%20And%20Diclofena
Description
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A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle

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