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

NCT00657449 | Terminated Phase 4

• 1 other identifier: A3471007
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 8

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.

Conditions

Acute Pain

Keywords

sprains and strains

Outcome Measures

Primary Outcomes (1)

• change from baseline in visual analogue scale (VAS) pain intensity

  Day 4

Secondary Outcomes (5)

• patient's assessment of ankle pain VAS (0-100 mm)

  Days 1, 4 and 8

• patient's and physician's global assessment of ankle injury

  Days 1, 4 and 8

• patient's and physician's satisfaction assessments

  Day 8

• patient's assessment of normal function/activity

  Days 1, 4 and 8

• adverse events, physical examinations, and baseline clinical laboratory values

  Adverse Events: Days 1, 4 and 8; Physical examinations: days 1 and 8; Lab tests: day 1

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Drug: valdecoxib

Arm 2

ACTIVE COMPARATOR

Drug: rofecoxib

Interventions

valdecoxib DRUG

valdecoxib 80 mg (two 40 mg tablets) by mouth on Day 1 and valdecoxib 40 mg tablet once daily on Days 2-8

Arm 1

rofecoxib DRUG

rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None reported

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Instituto Ortopedico de Goiania

Goiânia, Goiás, 74210-030, Brazil

Location

Centro de Traumatologia e Ortopedia

Goiânia, Goiás, Brazil

Location

Hospital Sao Zacarias

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, 90880480, Brazil

Location

Grupo Hospitalar Conceiçao

Porto Alegre, Rio Grande do Sul, 91350200, Brazil

Location

Hospital Geral do Grajau

São Paulo, São Paulo, 04822-320, Brazil

Location

Unifesp - Hsp

São Paulo, 04063003, Brazil

Location

SECONCI

São Paulo, 05001000, Brazil

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Acute Pain; Sprains and Strains

Interventions

valdecoxib; rofecoxib

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 14, 2008
• Study Start: June 4, 2003
• Primary Completion: October 1, 2004
• Study Completion: October 5, 2004
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

BR (8)