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Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee

Pain Clinical Trial

Official title:
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee

Clinical Trial Summary

This is a phase 2, randomized, double-blind, placebo-controlled trial of multiple doses and multiple administrations of LEVI-04 for the treatment of pain due to osteoarthritis of the knee.

Clinical Trial Description

The study consists of a Screening Period (including a Diary Run- In/analgesic wash-out Period), Randomization, Post-Randomization Period, and a Follow-up Period. Up to 624 participants will be enrolled and randomized to one of four Treatment Arms at the ratio 1:1:1:1 The overall objective of this study is to evaluate the efficacy and safety of LEVI-04 compared to placebo in patients with knee OA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05618782
Study type Interventional
Source Levicept
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 17, 2022
Completion date July 31, 2024
View Details
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