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"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Javier Maquirriain, Argentine Tennis Association Identifier:
First received: November 14, 2008
Last updated: August 2, 2013
Last verified: August 2013

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"

Resource links provided by NLM:

Further study details as provided by Argentine Tennis Association:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: August 2009
Study Completion Date: February 2012
Primary Completion Date: December 2011 (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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00792376

Argentine Tennis Association
Buenos Aires, Argentina
Sponsors and Collaborators
Argentine Tennis Association
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Javier Maquirriain, MD, Argentine Tennis Association Identifier: NCT00792376     History of Changes
Other Study ID Numbers: 00045-2008
Study First Received: November 14, 2008
Last Updated: August 2, 2013

Keywords provided by Argentine Tennis Association:

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 23, 2017