Clinical trial NCT00657449: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Pain
Keywords: sprains and strains
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: change from baseline in visual analogue scale (VAS) pain intensity
timeFrame: Day 4
Secondary outcomes:
measure: patient's assessment of ankle pain VAS (0-100 mm)
timeFrame: Days 1, 4 and 8
measure: patient's and physician's global assessment of ankle injury
timeFrame: Days 1, 4 and 8
measure: patient's and physician's satisfaction assessments
timeFrame: Day 8
measure: patient's assessment of normal function/activity
timeFrame: Days 1, 4 and 8
measure: adverse events, physical examinations, and baseline clinical laboratory values
timeFrame: Adverse Events: Days 1, 4 and 8; Physical examinations: days 1 and 8; Lab tests: day 1
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Instituto Ortopedico de Goiania
state: Goias
city: Goiania
country: Brazil
facility: Centro de Traumatologia e Ortopedia
state: Goiás
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: RIO Grande DO SUL
city: Rio de Janeiro
country: Brazil
facility: Hospital Sao Zacarias
state: RJ
city: Porto Alegre
country: Brazil
facility: Grupo Hospitalar Conceiçao
state: RS
city: São Paulo
country: Brazil
facility: Hospital Geral do Grajau
state: SP
city: São Paulo
country: Brazil
facility: Unifesp - Hsp
city: São Paulo
country: Brazil
facility: SECONCI
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: