Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00303056
First received: March 14, 2006
Last updated: February 15, 2012
Last verified: February 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
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.
| Enrollment: | 590 |
| Study Start Date: | February 2006 |
| Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
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 | |
| 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
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00303056 History of Changes |
| Other Study ID Numbers: | DRI6091, HOE140 |
| Study First Received: | March 14, 2006 |
| Last Updated: | February 15, 2012 |
| Health Authority: | United States: Food and Drug Administration Poland: Ministry of Health Czech Republic: State Institute for Drug Control |
Keywords provided by Sanofi:
|
Osteoarthritis knee |
Additional relevant MeSH terms:
|
Joint Diseases Osteoarthritis Osteoarthritis, Knee Musculoskeletal Diseases Arthritis Rheumatic Diseases Icatibant Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013