Back to results"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
Primary Purpose
Achilles Tendinopathy
Status
Completed
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
etoricoxib
diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendinopathy focused on measuring NSAID, tendon, pain, stiffness, Achilles
Eligibility 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.
Sites / Locations
- Argentine Tennis Association
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
etoricoxib
diclofenac
Arm Description
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.
Outcomes
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.
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.
Full Information
NCT ID
NCT00792376
First Posted
November 14, 2008
Last Updated
August 2, 2013
Sponsor
Argentine Tennis Association
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00792376
Brief Title
"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
Official Title
"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Argentine Tennis Association
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
Keywords
NSAID, tendon, pain, stiffness, Achilles
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
etoricoxib
Arm Type
Experimental
Arm Description
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
Arm Title
diclofenac
Arm Type
Active Comparator
Arm Description
diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
Intervention Type
Drug
Intervention Name(s)
etoricoxib
Intervention Description
etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Argentine Tennis Association
City
Buenos Aires
Country
Argentina
12. IPD Sharing Statement
Learn more about this trial
"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"
We'll reach out to this number within 24 hrs