drugset / Trial / NCT02067611
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IBUPROFEN TRELAMINE | Small molecule | — | Topical |