CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 216 enrolled
Drug / intervention
X0002 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02067611
NCT02067611Phase 2Completed

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

Lina Xu·interventional·Posted Feb 20, 2014·Updated Feb 7, 2018

In Brief

A Phase 2 clinical trial evaluating X0002 and Placebo for Osteoarthritis of the Knee. Completed, enrolled 216 participants across 20 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2014
Enrollment StartFeb 1, 2014
Primary CompletionAug 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.4 years ago

Interventions

X0002drug

Parallel Assignment

Placebodrug

Parallel Assignment