Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Núcleo de Estudos em Esportes e Ortopedia, Brazil.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Núcleo de Estudos em Esportes e Ortopedia, Brazil
ClinicalTrials.gov Identifier:
NCT00525993
First received: September 4, 2007
Last updated: October 20, 2008
Last verified: October 2008
  Purpose

The investigators will study 2 doses of etoricoxib to prove that 60 mg once daily will be non-inferior to etoricoxib 90mg daily (for 14 days) in the treatment of acute ankle sprain in sports. The investigators objective is to discuss the point that the investigators will follow the minimal dose that is effective for the treatment of this acute condition in orthopedic.


Condition Intervention Phase
Sprains and Strains
Contusions
Drug: etoricoxib 90mg 14 days
Drug: etoricoxib 60mg daily for 14 days
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of the Non-Steroidal Anti-Inflammatory Drug Etoricoxib in the Treatment of Acute Ankle Sprain in Sports: A Randomized Double-Blind Comparative Study Among 2 Treatments in the Acute Phase

Resource links provided by NLM:


Further study details as provided by Núcleo de Estudos em Esportes e Ortopedia, Brazil:

Primary Outcome Measures:
  • Reduction of pain during active mobilization measured using a visual analogue scale VAS at day 8 [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Volumetric measurement of the ankle and foot [ Time Frame: day 1 and day 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain during motion against resistance [ Time Frame: day 15 ] [ Designated as safety issue: No ]
  • Functional impairment and global assessment of efficacy by either patient and investigator [ Time Frame: day 15 ] [ Designated as safety issue: No ]
  • Tolerability will be assessed by the frequency of adverse experiences and global assessment of efficacy by either patient and investigator [ Time Frame: day 15 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: etoricoxib 60mg daily for 14 days
Patients in this group will receive 60mg of the drug, daily
Active Comparator: B Drug: etoricoxib 90mg 14 days
each patient in this group will receive 90mg once daily, for the 14 days treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients that suffered an ankle sprain in the last 12 hours and seek medical assistance

Exclusion Criteria:

  • anterior history of trauma / fractures in the affected ankle
  • history of hypertension / gastrointestinal problems
  • patients that did not agree to sign the informed consent to participate in the study
  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: NCT00525993

Contacts
Contact: Rogerio T Silva, MD, PhD 55.11.81716767 rgtsilva@uol.com.br
Contact: Adriana N Greggio 55.11.55495581 adi.adi@terra.com.br

Locations
Brazil
NEO Not yet recruiting
São Paulo, SP, Brazil, 04084100
Contact: Rogerio Silva    011 81716767    rgtsilva@uol.com.br   
Principal Investigator: Rogerio T Silva, MD, PhD         
Sub-Investigator: Fabio C Petri, MD         
Sponsors and Collaborators
Núcleo de Estudos em Esportes e Ortopedia, Brazil
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Rogerio T Silva, MD, PhD NEO - Orthopedic Sports Medicine Research Center
Study Director: Lidia F Souza, PT NEO - Orthopedic Sports Medicine Research Center
Study Director: Cristiano FS Laurino, MD NEO - Orthopedic Sports Medicine Research Center
  More Information

No publications provided

Responsible Party: Rogerio Teixeira da Silva, NEO - Núcleo de Estudos em Esportes e Ortopedia
ClinicalTrials.gov Identifier: NCT00525993     History of Changes
Other Study ID Numbers: NeoBrazil_EtoricoxibAnkle2007
Study First Received: September 4, 2007
Last Updated: October 20, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Núcleo de Estudos em Esportes e Ortopedia, Brazil:
sports
ankle
sprain
etoricoxib
antiinflammatory
treatment outcome

Additional relevant MeSH terms:
Sprains and Strains
Wounds and Injuries
Anti-Inflammatory Agents, Non-Steroidal
Etoricoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
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 20, 2014