Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2007
CompletedFirst Posted
Study publicly available on registry
September 6, 2007
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedOctober 21, 2008
October 1, 2008
8 months
September 4, 2007
October 20, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction of pain during active mobilization measured using a visual analogue scale VAS at day 8
8 days
Volumetric measurement of the ankle and foot
day 1 and day 8
Secondary Outcomes (3)
Pain during motion against resistance
day 15
Functional impairment and global assessment of efficacy by either patient and investigator
day 15
Tolerability will be assessed by the frequency of adverse experiences and global assessment of efficacy by either patient and investigator
day 15
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
each patient in this group will receive 90mg once daily, for the 14 days treatment.
Eligibility Criteria
You may qualify if:
- patients that suffered an ankle sprain in the last 12 hours and seek medical assistance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NEO
São Paulo, São Paulo, 04084100, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 4, 2007
First Posted
September 6, 2007
Study Start
December 1, 2008
Primary Completion
August 1, 2009
Study Completion
September 1, 2009
Last Updated
October 21, 2008
Record last verified: 2008-10