CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 423 enrolled
Drug / intervention
MEN16132 - 0.125 mg +4 moredrug
Likely dose
MEN16132 - 0.125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01091116
NCT01091116Phase 2Completed

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

Menarini Group·interventional·Posted Mar 23, 2010·Updated Feb 18, 2013

In Brief

A Phase 2 clinical trial evaluating MEN16132 - 0.125 mg, MEN16132 - 0.25 mg, and 2 other interventions for Osteoarthritis, Knee. Completed, enrolled 423 participants across 23 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Italy, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2010
Enrollment StartMar 1, 2010
Primary CompletionFeb 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.3 years ago

Interventions

MEN16132 - 0.125 mgdrug

Intra-articular administration of two low doses of MEN16132 at 2-week interval.

MEN16132 - 0.25 mgdrug

Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval

MEN16132 - 0.5 mgdrug

Intra-articular injection of two high doses of MEN16132 at 2-week interval

MEN16132 - 0.5 mgdrug

Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval

Placebodrug

Intra-articular injection of 2 doses of Placebo control at 2-week interval