NCT01091116

A Locally Injected Bradykinin Antagonist for TReatment of OSteoarthritiS

Intra-articular Treatment With MEN16132 in Patients With Symptomatic Primary Osteoarthritis of the Knee: A Randomized, Multi-centre, Double Blind, Placebo Controlled, Five Parallel Group, Dose Finding Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 423 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

Detailed description

MEN16132 is a non-peptide bradykinin B2-receptor antagonist showing analgesic and anti-inflammatory activity in nonclinical osteoarthritis models. This study is being conducted as a dose finding study to determine the safety and efficacy of MEN16132, given as three doses/four treatment regimens in comparison to placebo, as well the time to onset and duration of effect.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	MEN16132 - 0.125 mg	Intra-articular administration of two low doses of MEN16132 at 2-week interval.
DRUG	MEN16132 - 0.25 mg	Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval
DRUG	MEN16132 - 0.5 mg	Intra-articular injection of two high doses of MEN16132 at 2-week interval
DRUG	MEN16132 - 0.5 mg	Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
DRUG	Placebo	Intra-articular injection of 2 doses of Placebo control at 2-week interval

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2010-03-23
• Last updated: 2013-02-18
• Results posted: 2013-02-18

Locations

23 sites across 4 countries: France, Germany, Italy, Spain