Trial record 12 of 23 for: ICATIBANT

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

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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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Joint Disease	Drug: HOE140 Icatibant	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	590 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	February 2006
Actual Primary Completion Date :	July 2007
Actual Study Completion Date :	July 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Osteoarthritis

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Icatibant Icatibant acetate

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303056

Locations

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

Sponsors and Collaborators

Sanofi

Investigators

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Study Director:	Clinical Sciences & Operations	Sanofi

More Information

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Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00303056 History of Changes
Other Study ID Numbers:	DRI6091 HOE140
First Posted:	March 15, 2006 Key Record Dates
Last Update Posted:	February 17, 2012
Last Verified:	February 2012

Keywords provided by Sanofi:


Osteoarthritis knee

Additional relevant MeSH terms:

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Icatibant Osteoarthritis Osteoarthritis, Knee Joint Diseases Arthritis Musculoskeletal Diseases Rheumatic Diseases Bradykinin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Bradykinin B2 Receptor Antagonists Bradykinin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Vasodilator Agents

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