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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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Núcleo de Estudos em Esportes e Ortopedia, Brazil.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00525993
First Posted: September 6, 2007
Last Update Posted: October 21, 2008
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Núcleo de Estudos em Esportes e Ortopedia, Brazil
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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

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 ]
  • Volumetric measurement of the ankle and foot [ Time Frame: day 1 and day 8 ]

Secondary Outcome Measures:
  • Pain during motion against resistance [ Time Frame: day 15 ]
  • Functional impairment and global assessment of efficacy by either patient and investigator [ Time Frame: day 15 ]
  • Tolerability will be assessed by the frequency of adverse experiences and global assessment of efficacy by either patient and investigator [ Time Frame: day 15 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 4, 2007
First Posted: September 6, 2007
Last Update Posted: October 21, 2008
Last Verified: October 2008

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
Ankle Injuries
Contusions
Wounds and Injuries
Leg Injuries
Wounds, Nonpenetrating
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents