NCT02067611

A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis

A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, Dose Range Finding Study to Evaluate the Efficacy and Safety of X0002 Spray Versus Placebo in Subjects With Osteoarthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Lina Xu · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee. Objectives of the study: 1. To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in subjects with osteoarthritis (OA) of the knee; 2. To assess the safety and tolerability of multiple doses of X0002 when administered as a topical spray.

Detailed description

This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee. After a screening period of up to 3 weeks and radiographic evaluation of the target knee joint space, 225 subjects will be randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group (i.e., 2 subjects to active treatment and 1 subject to placebo): Group A: low dose of X0002, twice daily (BID, approximately every 12 hours; n=50) or placebo (low dose), BID (approximately every 12 hours; n=25); Group B: middle dose of X0002, BID (approximately every 12 hours; n=50) or placebo , BID (approximately every 12 hours; n=25) ; Group C: High dose of X0002, BID (approximately every 12 hours; n=50) or placebo, BID (approximately every 12 hours; n=25) . Safety and efficacy assessments will be performed at at 2, 4, 8, and 12 weeks of treatment.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	X0002	Parallel Assignment
DRUG	Placebo	Parallel Assignment

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-08-01
• Completion: 2016-04-01
• First posted: 2014-02-20
• Last updated: 2018-02-07
• Results posted: 2018-02-07

Locations

20 sites across 1 country: United States