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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Javier Maquirriain, Argentine Tennis Association
ClinicalTrials.gov Identifier:
NCT00792376
First received: November 14, 2008
Last updated: August 2, 2013
Last verified: August 2013
  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 4

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"

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792376

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

No publications provided

Responsible Party: Javier Maquirriain, MD, 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: August 2, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Argentine Tennis Association:
NSAID
tendon
pain
stiffness
Achilles

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 24, 2014