Efficacy and Safety Study of Intra-Articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00303056

Purpose

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	Intervention	Phase
Joint Disease	Drug: HOE140 Icatibant	Phase II

MedlinePlus related topics: Joint Disorders Osteoarthritis

Drug Information available for: Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide Icatibant Icatibant acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

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.

Estimated Enrollment:	550
Study Start Date:	February 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303056

Locations

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

Sponsors and Collaborators

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	DRI6091, HOE140
Study First Received:	March 14, 2006
Last Updated:	April 20, 2007
ClinicalTrials.gov Identifier:	NCT00303056
Health Authority:	United States: Food and Drug Administration; Poland: Ministry of Health; Czech Republic: State Institute for Drug Control

Keywords provided by Sanofi-Aventis:

Osteoarthritis
knee

Study placed in the following topic categories:

Osteoarthritis, Knee
Triamcinolone Acetonide
Musculoskeletal Diseases
Osteoarthritis
Arthritis
Joint Diseases

Triamcinolone
Triamcinolone diacetate
Pain
Rheumatic Diseases
Icatibant
Triamcinolone hexacetonide

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Adrenergic beta-Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Adrenergic Antagonists
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009