NCT00792376

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 6, 2013

Status Verified

August 1, 2013

Enrollment Period

2.3 years

First QC Date

November 14, 2008

Last Update Submit

August 2, 2013

Conditions

Achilles Tendinopathy

Keywords

NSAIDtendonpainstiffnessAchilles

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

etoricoxib

EXPERIMENTAL

etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days

Drug: etoricoxibDrug: diclofenac

diclofenac

ACTIVE COMPARATOR

diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.

Drug: diclofenac

Interventions

etoricoxibDRUG

etoricoxib (ETO) group (n=28) treated with etoricoxib 120 mg/day orally for 7 days

etoricoxib
diclofenacDRUG

diclofenac (DIC) group (n=28) received diclofenac 150 mg/day/7 days orally.

diclofenacetoricoxib

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Argentine Tennis Association

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Pain

Interventions

EtoricoxibDiclofenac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 17, 2008

Study Start

August 1, 2009

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

August 6, 2013

Record last verified: 2013-08

Locations

AR(1)