Clinical Trials Logo
  1. Home
  2. Knee Osteoarthritis
  3. NCT06463132

Phase 1b Clinical Trial to Evaluate PEP and EUFLEXXA for Knee Osteoarthritis (KOA)

Knee Osteoarthritis Clinical Trial

Official title:
Phase 1b Open-Label, Multi-Center, Randomized Trial to Evaluate the Safety of PEP and EUFLEXXA for the Treatment of Subjects With Knee Osteoarthritis (KOA)

Clinical Trial Summary

Evaluate the safety and exploratory efficacy of single intra-articular injections of PEP reconstituted with 0.9% Normal Saline at a low dose (one vial PEP) and high dose (two vials PEP), with and without EUFLEXXA, for the treatment of Knee Osteoarthritis

Clinical Trial Description

Study Plan (with Dose Escalation): Arm 1 and Arm 2 will run in parallel such that initially 3 subjects will be enrolled in Arm 1a (PEP Low Dose) and 3 subjects will be enrolled in Arm 2a (PEP-EUFLEXXA Low Dose). After all 6 subjects complete the 30 day follow up and there was not more than 1 AE grade 3 or higher per Arm, a further 9 subjects will be enrolled in Arm 1b (PEP High Dose) and a further 9 subjects will be enrolled in Arm 2b (PEP-EUFLEXXA High Dose). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06463132
Study type Interventional
Source Rion Inc.
Contact Shariq Khan, M.S.
Phone 847-702-4063
Email khan@riontx.com
Status Not yet recruiting
Phase Phase 1
Start date November 1, 2024
Completion date November 1, 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04651673 - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed NCT05677399 - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise. N/A
Active, not recruiting NCT04043819 - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis Phase 1
Recruiting NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee Phase 3
Completed NCT05014542 - Needling Techniques for Knee Osteoarthritis N/A
Recruiting NCT05892133 - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty N/A
Recruiting NCT05528965 - Parallel Versus Perpendicular Technique for Genicular Radiofrequency N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting NCT02003976 - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone N/A
Active, not recruiting NCT04017533 - Stability of Uncemented Medially Stabilized TKA N/A
Completed NCT04779164 - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis N/A
Recruiting NCT04006314 - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis N/A
Recruiting NCT05423587 - Genicular Artery Embolisation for Knee Osteoarthritis II N/A
Enrolling by invitation NCT04145401 - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting NCT03781843 - Effects of Genicular Nerve Block in Knee Osteoarthritis N/A
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05324163 - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis Phase 3
Completed NCT05529914 - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis N/A
Recruiting NCT05693493 - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA? N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A