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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657449
Recruitment Status : Terminated (See Detailed Description)
First Posted : April 14, 2008
Last Update Posted : April 14, 2008
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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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: valdecoxib Drug: rofecoxib Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Valdecoxib

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. change from baseline in visual analogue scale (VAS) pain intensity [ Time Frame: Day 4 ]

Secondary Outcome Measures :
  1. patient's assessment of ankle pain VAS (0-100 mm) [ Time Frame: Days 1, 4 and 8 ]
  2. patient's and physician's global assessment of ankle injury [ Time Frame: Days 1, 4 and 8 ]
  3. patient's and physician's satisfaction assessments [ Time Frame: Day 8 ]
  4. patient's assessment of normal function/activity [ Time Frame: Days 1, 4 and 8 ]
  5. 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 ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657449

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, 04063003
Pfizer Investigational Site
São Paulo, Brazil, 05001000
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00657449     History of Changes
Other Study ID Numbers: A3471007
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: April 14, 2008
Last Verified: March 2008

Keywords provided by Pfizer:
sprains and strains

Additional relevant MeSH terms:
Acute Pain
Sprains and Strains
Ankle Injuries
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Wounds and Injuries
Leg Injuries
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents