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Phase II Study of AP0302 5% Versus a Vehicle Comparator

NCT02324985 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2019-02-25

No results posted yet for this study

Summary

This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.

Conditions

  • Pain
  • Delayed Onset Muscle Soreness

Interventions

DRUG

S-Ibuprofen Topical Gel 5%

S-Ibuprofen Topical Gel 5% applied every 6 hours

DRUG

Vehicle Topical Gel

Vehicle Topical Gel applied every 6 hours

Sponsors & Collaborators

  • Aponia Laboratories, Inc.

    lead INDUSTRY

Principal Investigators

  • Sonia Singla, DO · Lotus Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-07-31
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02324985 on ClinicalTrials.gov