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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00303056
Recruitment Status : Completed
First Posted : March 15, 2006
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE March 14, 2006
First Posted Date  ICMJE March 15, 2006
Last Update Posted Date February 17, 2012
Study Start Date  ICMJE February 2006
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2006)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00303056 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2006)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis
Official Title  ICMJE 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
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Joint Disease
Intervention  ICMJE Drug: HOE140 Icatibant
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2012)
590
Original Enrollment  ICMJE
 (submitted: March 14, 2006)
550
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Czech Republic,   Germany,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00303056
Other Study ID Numbers  ICMJE DRI6091
HOE140
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date February 2012

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