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

Purpose

We will study 2 doses of etoricoxib to prove that 60 mg once daily (14 days) will be non-inferior to etoricoxib 120 mg daily (7 days) followed by etoricoxib 90mg daily (for 7 days) in the treatment of acute ankle sprain in sports. Our objective is to discuss the point that we 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 120mg 7 days / 90mg 7 days Drug: etoricoxib 60mg daily for 14 days	Phase IV

MedlinePlus related topics:

Bruises

ChemIDplus related topics:

Etoricoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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 ] [ 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:	July 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: etoricoxib 60mg daily for 14 days Patients in this group will receive two boxes containing 2 pills each (each pill will have placebo or etoricoxib 30mg - corresponding to the dose of 60 mg per day)
B: Active Comparator	Drug: etoricoxib 120mg 7 days / 90mg 7 days Patients in this group will receive two boxes containing 2 pills each (each pill will have placebo or etoricoxib 30mg - corresponding to the doses described above)

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, SP
	NEO	Not yet recruiting
	São Paulo, SP, Brazil, 04084100
	Contact: Rogerio Silva 011 81716767 rgtsilva@uol.com.br
	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

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:	NEO - Núcleo de Estudos em Esportes e Ortopedia ( Rogerio Teixeira da Silva )
Study ID Numbers:	NeoBrazil_EtoricoxibAnkle2007
First Received:	September 4, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00525993
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

Study placed in the following topic categories:

Contusions

Etoricoxib

Wounds and Injuries

Disorders of Environmental Origin

Wounds, Nonpenetrating

Sprains and Strains

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Cyclooxygenase Inhibitors

Physiological Effects of Drugs

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	Núcleo de Estudos em Esportes e Ortopedia, Brazil Merck Sharp & Dohme
Information provided by:	Núcleo de Estudos em Esportes e Ortopedia, Brazil
ClinicalTrials.gov Identifier:	NCT00525993