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

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792376
• Other study ID #: 00045-2008
• Secondary ID: 1-47-12225-05-1
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2008
• Last updated: August 2, 2013
• Start date: August 2009
• Est. completion date: February 2012

Study information

• Verified date: August 2013
• Source: Argentine Tennis Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Drug:
• etoricoxib
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
• diclofenac
diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.

Locations

Country	Name	City	State
Argentina	Argentine Tennis Association	Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Argentine Tennis Association	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 week	Yes
Secondary	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.		1 week	Yes