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

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00657449
First received: March 31, 2008
Last updated: April 8, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Acute Pain
Drug: valdecoxib
Drug: rofecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • change from baseline in visual analogue scale (VAS) pain intensity [ Time Frame: Day 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient's assessment of ankle pain VAS (0-100 mm) [ Time Frame: Days 1, 4 and 8 ] [ Designated as safety issue: No ]
  • patient's and physician's global assessment of ankle injury [ Time Frame: Days 1, 4 and 8 ] [ Designated as safety issue: No ]
  • patient's and physician's satisfaction assessments [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • patient's assessment of normal function/activity [ Time Frame: Days 1, 4 and 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 256
Study Start Date: June 2003
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 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
Active Comparator: Arm 2 Drug: rofecoxib
rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657449

Locations
Brazil
Pfizer Investigational Site
Goiania, Goias, Brazil, 74210-030
Pfizer Investigational Site
Goiania, Goiás, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil, 90880480
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 91350200
Pfizer Investigational Site
São Paulo, SP, Brazil, 04822-320
Pfizer Investigational Site
São Paulo, Brazil, 05001000
Pfizer Investigational Site
São Paulo, Brazil, 04063003
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00657449     History of Changes
Other Study ID Numbers: A3471007
Study First Received: March 31, 2008
Last Updated: April 8, 2008
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Pfizer:
sprains and strains

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Rofecoxib
Valdecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014