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| Sponsor: | Argentine Tennis Association |
|---|---|
| Information provided by: | Argentine Tennis Association |
| ClinicalTrials.gov Identifier: | NCT00792376 |
Purpose
The purpose of this study is to evaluate etoricoxib efficacy in pain control, leg stiffness and functional recovery of patients suffering acute Achilles tendinopathy.
It is hypothesized that etoricoxib (120mg orally/day/7 days) efficacy is not inferior to diclofenac (150mg orally /day/7 days) for pain control in subjects suffering acute Achilles tendinopathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Achilles Tendinopathy |
Drug: etoricoxib Drug: diclofenac |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | "NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes" |
| Estimated Enrollment: | 56 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: etoricoxib
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
|
Drug: etoricoxib
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
Drug: diclofenac
diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
|
|
Active Comparator: diclofenac
diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
|
Drug: diclofenac
diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Javier Maquirriain, MD | 54 9 11 4478 8367 | jmaquirriain@yahoo.com |
| Contact: Vanesa Vinciunas | 54 9 341 5855555 | vanuvin@yahoo.com.ar |
| Argentina | |
| Argentine Tennis Association | Not yet recruiting |
| Buenos Aires, Argentina | |
| Contact: Gustavo Represas gusrep@hotmail.com | |
| Principal Investigator: Javier Maquirriain, MD, PhD | |
More Information
| Responsible Party: | Javier Maquirriain MD, PhD, Argentine Tennis Association |
| ClinicalTrials.gov Identifier: | NCT00792376 History of Changes |
| Other Study ID Numbers: | 00045-2008, 1-47-12225-05-1 |
| Study First Received: | November 14, 2008 |
| Last Updated: | November 14, 2008 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
|
NSAID tendon pain stiffness Achilles |
|
Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries 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 |