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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02195505
Other study ID # 1139.1
Secondary ID
Status Completed
Phase N/A
First received July 18, 2014
Last updated July 18, 2014
Start date September 2001

Study information

Verified date July 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority France: Conseil National de l'Ordre des Médecins
Study type Observational

Clinical Trial Summary

The USAGE study aims at assessing on a long-term period (two years in average) the outcome in clinical or economical term of patients with knee osteoarthritis (OA) treated or not with Synvisc®, in the 1139.4 clinical trial.


Recruitment information / eligibility

Status Completed
Enrollment 374
Est. completion date
Est. primary completion date April 2002
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients have already been followed up on a nine-month period in a pragmatic medica-economical clinical trial (BI Trial No.: 1139.4)

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Lequesne index assessment of algo-functional severity of pathology up to 2 years No
Primary Change in Womac index assessment of symptom severity up to 2 years No
Secondary Medical costs related to knee osteoarthritis up to 2 years No
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