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Phase 2 Efficacy Trial of OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With OA of the Knee

NCT01768975 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2014-10-06

No results posted yet for this study

Summary

The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

OLT1177 Gel

4 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1

OTHER

Placebo gel

Identical dose and dosing regimen as the Investigational Drug (OLT1177 Gel)

Sponsors & Collaborators

  • Olatec Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Jaime A. Pachon, MD · Miami Research Associates

  • Bruce G. Rankin, D.O., C.P.I · Avail Clinical Research

  • Treva W. Tyson, MD · Wake Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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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 NCT01768975 on ClinicalTrials.gov