Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols
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| ClinicalTrials.gov Identifier: NCT00525993 |
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Recruitment Status
: Unknown
Verified October 2008 by Núcleo de Estudos em Esportes e Ortopedia, Brazil.
Recruitment status was: Not yet recruiting
First Posted
: September 6, 2007
Last Update Posted
: October 21, 2008
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Sponsor:
Núcleo de Estudos em Esportes e Ortopedia, Brazil
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Núcleo de Estudos em Esportes e Ortopedia, Brazil
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Sprains and Strains Contusions | Drug: etoricoxib 90mg 14 days Drug: etoricoxib 60mg daily for 14 days | Phase 4 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| 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 |
| Study Start Date : | December 2008 |
| Estimated Primary Completion Date : | August 2009 |
| Estimated Study Completion Date : | September 2009 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: A |
Drug: etoricoxib 60mg daily for 14 days
Patients in this group will receive 60mg of the drug, daily
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| Active Comparator: B |
Drug: etoricoxib 90mg 14 days
each patient in this group will receive 90mg once daily, for the 14 days treatment.
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Primary Outcome Measures
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- 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
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- 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 ]
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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
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 |
| 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 Posted: | September 6, 2007 Key Record Dates |
| Last Update Posted: | October 21, 2008 |
| Last Verified: | October 2008 |
Keywords provided by Núcleo de Estudos em Esportes e Ortopedia, Brazil:
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sports ankle sprain |
etoricoxib antiinflammatory treatment outcome |
Additional relevant MeSH terms:
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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 |