Overview

Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis

Status:
Completed

Trial end date:
2007-07-01

Target enrollment:
0

Participant gender:
All

Summary

The primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo. The secondary objectives are to assess the efficacy of icatibant in term of onset, extent and duration of pain relief relative to triamcinolone, to evaluate the safety of icatibant, to evaluate overall conditions of daily life after treatment with icatibant, to assess systemic exposure of icatibant following intra-articular injection.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sanofi

Treatments:

Bradykinin
Icatibant

Criteria

Inclusion Criteria:

- Male and female subjects with painful osteoarthritis of the knee.

Exclusion Criteria:

- Subjects presenting with diagnosis of OA < 3 months and an OA grading < K&L grade II,
with any condition with impact on on the target indication, any test-compound-related
condition, any study-related condition (all those conditions detailled in the CSP).