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

NCT02067611 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2018-02-07

Study results available
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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.

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

X0002

Parallel Assignment

DRUG

Placebo

Parallel Assignment

Sponsors & Collaborators

  • Lina Xu

    lead INDUSTRY

Principal Investigators

  • Chongxi Yu, Ph.D. · Techfields Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-08-31
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02067611 on ClinicalTrials.gov