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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00303056
First received: March 14, 2006
Last updated: February 15, 2012
Last verified: February 2012
History of Changes

March 14, 2006
February 15, 2012
February 2006
July 2007   (final data collection date for primary 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).
Same as current
Complete list of historical versions of study NCT00303056 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Joint Disease
Drug: HOE140 Icatibant
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
590
July 2007
July 2007   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Czech Republic,   Germany,   Poland
 
NCT00303056
DRI6091, HOE140
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP