Safety of Use and Efficacy of Pandora for Patients Suffering From Gonarthrosis (PANDORA2) — PANDORA2

Knee Osteoarthritis Clinical Trial

Official title:
Prospective, Multicenter, Randomized, Parallel Groups Study Comparing the Safety and the Efficacy of the Administration of One Intra-articular Injection of 4.8 ml (HO-1) or Three Intra-articular Injections of 2.2 ml (HS-3) of Pandora Gel to One Intra-articular Injection of 2.5 ml (SINOVIAL®ONE), in Symptomatic Gonarthrosis

Status Recruiting

Clinical Trial Summary

The knee osteoarthritis is a frequent degenerative condition that mainly affects subjects over 60, population often weakened by numerous comorbidities and concomitant treatments, justifying the development of new therapies. The viscosupplementation is a symptomatic treatment for knee osteoarthritis ; the objective of this intra-articular injection of hyaluronic acid is to reduce knee pain and improve mobility. In practice, there are two protocols to administer viscosupplementation : in a single injection or in three injections performed weekly. The present clinical investigation has the objective to evaluate the safety and efficacy of use of Pandora, a hyaluronic acid associated with tranexamic acid, in a single injection (HO-1) or in three injections performed weekly (HS-3), compared to a referred and commercialized medical device.

Clinical Trial Description

This clinical investigation is a prospective, multicenter, randomized, parallel groups study of a class III Medical Device. This study is designed to compare the safety of use and the efficacy of Pandora in its two forms : in a single injection (HO-1) or in three injections (HS-3) to a single intra-articular injection of 2.5 ml (SINOVIAL®ONE) A descriptive analysis will be carried out to characterize the demographic data, the history of the disease and its treatments, the clinical and radiological data of the patients at inclusion. The efficacy of Pandora will be demonstrated by describing the variation of WOMAC A1 score "walking pain" of target knee in repeated measures. In total, 252 participants will be enrolled across 40 study centers in France and Monaco. The total duration of subjects' participation is 12 months ; overall study duration including the enrollment period is expected to take approximately 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05978180
Study type	Interventional
Source	Labrha
Contact	Leslie Genet
Phone	06 82 29 36 07
Email	leslie.genet@labrha.com
Status	Recruiting
Phase	N/A
Start date	October 18, 2023
Completion date	October 30, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.