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| Sponsor: | University of Cape Town |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | University of Cape Town |
| ClinicalTrials.gov Identifier: | NCT00954785 |
Purpose
The aim of the study is to measure the effectiveness of treatment over 7 days with commonly used anti-inflammatory medications namely etoricoxib and diclofenac (Voltaren) on reducing the severity of pain, swelling and loss of function (range of movement, proprioception) arising from a mild to moderate sprain (partial tear) of the lateral (outer) ligaments of the ankle joint. This injury is commonly known as an ankle sprain.
| Condition | Intervention | Phase |
|---|---|---|
|
Sprain |
Device: Ankle brace Drug: Diclofenac 50 mg tds Drug: Etoricoxib 120 mg mane |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | The Efficacy and Safety of Administration of the COX-2 Selective NSAID, Etoricoxib (120mg od. for 7 Days) Compared to Diclofenac (50 mg Tds. for 7 Days) and Placebo as Adjunct Treatment in the First 7 Days of Treatment of Acute Grade II Lateral Ankle Ligaments Sprains: A Clinical Trial |
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo drug |
Device: Ankle brace
Sports Stirrup ankle brace (Aircast)
|
| Experimental: Etoricoxib |
Device: Ankle brace
Sports Stirrup ankle brace (Aircast)
Drug: Etoricoxib 120 mg mane
In the etoricoxib group, each subject will receive 120 mg etoricoxib in the morning, and placebo medication in the evening and at mid-day
Other Name: Arcoxia
|
| Active Comparator: Diclofenac |
Device: Ankle brace
Sports Stirrup ankle brace (Aircast)
Drug: Diclofenac 50 mg tds
In the diclofenac group, each subject will receive 50 mg diclofenac in the morning, at mid-day and in the evening
Other Name: Voltaren
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Grade II ankle sprain injury according to the following: (Rationale: Standard clinical criteria are used to ensure that the severity of injury is similar in all subjects)
Exclusion Criteria:
Contacts and Locations| Contact: Martin P Schwellnus, MBBCh, MD | +27216504562 | martin.schwellnus@uct.ac.za |
| Contact: Wayne Derman, MBBCh, PhD | +27216504562 | wayne.derman@uct.ac.za |
| South Africa | |
| Sports Medicine Clinic, Sports Science Institute of South Africa | Not yet recruiting |
| Cape Town, Western Cape, South Africa, 7700 | |
| Contact: Martin P Schwellnus, MBBCh, MD +27216504562 martin.schwellnus@uct.ac.za | |
| Contact: Wayne Derman, MBBCh, PhD +27216504562 wayne.derman@uct.ac.za | |
| Principal Investigator: Martin P Schwellnus, MBBCh, MD | |
| Sub-Investigator: Wayne Derman, MBBCh, PhD | |
| Sub-Investigator: Karen Schwabe, MBBCh, MPhil (Sports Medicine) | |
| Sub-Investigator: Jeroen Swart, MBBCh, MPhil (Sports Medicine) | |
| Kuilsriver Netcare Hospital, 33 Van Riebeeck Road, Kuilsriver | Not yet recruiting |
| Cape Town, Western Cape, South Africa, 7580 | |
| Contact: Martin P Schwellnus, MBBCh, MD +27834543783 martin.schwellnus@uct.ac.za | |
| Contact: Wayne Derman, MBBCh, PhD +27834543784 wayne.derman@uct.ac.za | |
| Principal Investigator: Martin P Schwellnus, MBBCh. MD | |
| Sub-Investigator: Wayne Derman, MBBCh, PhD | |
| Sub-Investigator: Karen Schwabe, MBBCh, MPhil (Sports medicine) | |
| Sub-Investigator: Jeroen Swart, MBBCh, MPhil (Sports Medicine) | |
| Principal Investigator: | Martin P Schwellnus, MBBCh, MD | University of Cape Town |
More Information
| Responsible Party: | Martin Schwellnus, Prof, University of Cape Town |
| ClinicalTrials.gov Identifier: | NCT00954785 History of Changes |
| Other Study ID Numbers: | IISP 34251, Rec Ref 005/2008 |
| Study First Received: | August 6, 2009 |
| Last Updated: | August 10, 2009 |
| Health Authority: | South Africa: Medicines Control Council; United States: Food and Drug Administration |
|
ankle ligament sprain |
non-steroidal anti-inflammatory drugs treatment Acute ankle ligament sprain |
|
Sprains and Strains Wounds and Injuries Anti-Inflammatory Agents, Non-Steroidal Diclofenac Etoricoxib Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |