- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00792376
"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
August 2, 2013 updated by: Javier Maquirriain, Argentine Tennis Association
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina
- Argentine Tennis Association
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Patients are eligible if they are male between 18 and 50 years of age and they suffer acute Achilles tendinopathy (<2 weeks). Diagnosis of Achilles tendinopathy is made by means of activity-related achillodynia, morning stiffness or pain, painful one-legged jumping test, tenderness and decreased sports performance (26). Subjects' age, race, affected tendon (right, left), activity, height and weight will be recorded.
Exclusion Criteria:
- Patients are excluded from the study if they have:
- Prior lower limb surgery or major trauma.
- Bilateral Achilles tendinopathy.
- History of lower limb radiculo-neuropathy or miopathy.
- Hypersensitivity to any NSAIDs.
- Used analgesic agents (NSAIDs, salicilates, narcotic) within 1 week
- Concurrent medical/arthritic disease (e.g. gout, lupus, rheumatoid arthritis).
- Other concurrent medical conditions including diabetes, hypertension, angina or congestive heart failure, ischaemic cardiopathy, malabsorption, morbid - Personal history of renal dysfunction, hepatic dysfunction or anemia
- Used corticosteroids, clopidogrel bisulphate, rifampin, quinolon antibiotics, antiepileptics, muscle relaxants, warfarin, ticlopidine, glucosamine, condroitin sulphate for < 6 months prior to the study start. Patients taking low dose aspirin (100 mg) for cardioprotective benefit will be also excluded. Any other medication consumption will be considered by the investigator and the Ethical Committee.
- Any other condition which, in the opinion of the investigator, could confound the study results or pose a risk to the patient (for example, co-morbid conditions for which NSAIDs are contraindicated).
- History of psychotic illness, dementia or depression
- History of drug or alcohol abuse or dependence.
- Participated in any previous NSAIDs study and received active treatment, or in an investigational trial within 30 days prior to the first visit.
- Inability to communicate or to cooperate with the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: etoricoxib
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
|
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
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.
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diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The pre-defined primary efficacy endpoint of the study is a 100-mm pain visual analog scale (P-VAS), where 0= no pain; 100= extreme pain.
Time Frame: 1 week
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1 week
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary study endpoints includes: the VISA-A Questionnaire, the Achilles Tendinopathy Scoring System (ATSS), PGART using a 5-point Likert scale and leg functional stiffness.
Time Frame: 1 week
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1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
November 14, 2008
First Submitted That Met QC Criteria
November 14, 2008
First Posted (Estimate)
November 17, 2008
Study Record Updates
Last Update Posted (Estimate)
August 6, 2013
Last Update Submitted That Met QC Criteria
August 2, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Musculoskeletal Diseases
- Muscular Diseases
- Tendon Injuries
- Tendinopathy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Diclofenac
- Etoricoxib
Other Study ID Numbers
- 00045-2008
- 1-47-12225-05-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Achilles Tendinopathy
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University of CalgarySport Science Association of Alberta (SSAA)UnknownAchilles Tendinopathy | Achilles Tendon Enthesopathy | Mid-Portion Achilles Tendinopathy | Insertional Achilles Tendinopathy | Non-Insertional Achilles TendinopathyCanada
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Krankenhaus Barmherzige Schwestern LinzActive, not recruitingAchilles Tendinopathy | Insertional Achilles TendinopathyAustria
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University of DelawareActive, not recruitingAchilles Tendinopathy | Achillodynia | Achilles Tendon Pain | Achilles Tendonitis | Achilles DegenerationUnited States
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Guna S.p.aRecruitingTendinopathy | Achilles Tendinopathy | Insertional Achilles Tendinopathy | PeritendinitisItaly
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University of DelawareRecruitingSever's Disease | Achilles Tendinopathy | Insertional Achilles Tendinopathy | Apophysitis; CalcaneusUnited States
-
University of Gran RosarioRecruitingTendon Injuries | Achilles Tendinopathy | Achilles Tendon PainArgentina
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Chinese University of Hong KongNot yet recruiting
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North Park PodiatryRecruiting
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