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
Recruitment status was Not yet recruiting
Sponsor:
Núcleo de Estudos em Esportes e Ortopedia, Brazil
Collaborator:
Merck
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
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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
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
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:
|
Contusions Sprains and Strains Wounds and Injuries Wounds, Nonpenetrating Etoricoxib Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013