drugset / Trial / NCT02067611

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

NCT02067611

Phase 2 Completed 216 enrolled Lina Xu
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-02
Primary completion
2015-08
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject IBUPROFEN TRELAMINE Small molecule Topical

Indications