CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 446 enrolled
Drug / intervention
Hyaluronic acid +1 moredevice
Likely dose
Not stated in 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/NCT00669032
NCT00669032N/ACompleted

Random, Phase IV, Multicentre, Double Blind, Placebo Controlled, Parallel Study to Assess Long-term Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid (ADANT®) in Patients With Knee OA of the Knee

Tedec-Meiji Farma, S.A.·interventional·Posted Apr 29, 2008·Updated Aug 28, 2023

In Brief

A clinical study evaluating Hyaluronic acid and Placebo for Osteoarthritis of the Knee. Completed, enrolled 446 participants.

Detailed Summary

The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 29, 2008
Enrollment StartOct 1, 2003
Primary CompletionJul 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.2 years ago

Interventions

Hyaluronic aciddevice

3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Placeboother

3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year