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

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00657449
• Other study ID #: A3471007
• Status: Terminated
• Phase: Phase 4
• Start date: June 4, 2003
• Est. completion date: October 5, 2004

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A3471007 terminated early (30Sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by Merck & Co Inc

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: October 5, 2004
• Est. primary completion date: October 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Ankle Injuries
• Sprains and Strains

Intervention

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

Locations

Country	Name	City	State
Brazil	Centro de Traumatologia e Ortopedia	Goiania	Goiás
Brazil	Instituto Ortopedico de Goiania	Goiania	Goias
Brazil	Grupo Hospitalar Conceiçao	Porto Alegre	RS
Brazil	Hospital Mãe de Deus	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital Sao Zacarias	Rio de Janeiro	RJ
Brazil	Hospital Geral do Grajau	São Paulo	SP
Brazil	SECONCI	São Paulo
Brazil	Unifesp - Hsp	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in visual analogue scale (VAS) pain intensity		Day 4
Secondary	patient's assessment of ankle pain VAS (0-100 mm)		Days 1, 4 and 8
Secondary	patient's and physician's global assessment of ankle injury		Days 1, 4 and 8
Secondary	patient's and physician's satisfaction assessments		Day 8
Secondary	patient's assessment of normal function/activity		Days 1, 4 and 8
Secondary	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

External Links

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