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

February 15, 2012 updated by: Sanofi

Efficacy and Safety of Intra-articular Multiple Doses of 500 µg Icatibant Including 40 mg Triamcinolone as Calibrator in a Randomized, Double-blind, Parallel-group, Placebo-controlled 13-week Multi-centre Study in Patients With Symptomatic Knee Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multinational, randomized, placebo-controlled study to be conducted in Europe and the US. Study medication will be administered by intra-articular injection 3 times in weekly intervals, being followed by an observation period of further 11 weeks.

Study Type

Interventional

Enrollment (Actual)

590

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, DCA 1220
        • Administrative Office
  • Czech Republic
      • Praha, Czech Republic, 160 00
        • Administrative Office
  • Germany
      • Berlin, Germany, D-10785
        • Administrative Office
  • Poland
      • Warszawa, Poland, 02-672
        • Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain during activity, at rest and at night will be measured daily via an electronic patient diary (EPD) using a 100-unit visual analog scale (VAS).

Secondary Outcome Measures

Outcome Measure
Patient global assessment assessed daily as well as WOMAC scores at each visit and intake of rescue medication daily via EPD recording. Safety assessed at each visit and pharmacokinetics at visits 2, 3 & 4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

March 14, 2006

First Submitted That Met QC Criteria

March 14, 2006

First Posted (Estimate)

March 15, 2006

Study Record Updates

Last Update Posted (Estimate)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 15, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI6091
  • HOE140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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