"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
NCT ID: NCT00792376
Last Updated: 2013-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2009-08-31
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
etoricoxib
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
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.
diclofenac
diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
diclofenac
diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
50 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Argentine Tennis Association
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Javier Maquirriain
MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Argentine Tennis Association
Buenos Aires, , Argentina
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1-47-12225-05-1
Identifier Type: -
Identifier Source: secondary_id
00045-2008
Identifier Type: -
Identifier Source: org_study_id