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Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS

NCT03852459 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2022-01-25

Study results available
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Summary

Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%

Conditions

  • Pain, Acute

Interventions

DRUG

S-Ibuprofen

Topical Gel 5%

DRUG

Vehicle

Vehicle Gel

Sponsors & Collaborators

  • Aponia Laboratories, Inc.

    lead INDUSTRY

Principal Investigators

  • Todd Bertoch, MD · JBR Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2019-04-04
Completion
2019-04-11
FDA Drug
Yes

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 NCT03852459 on ClinicalTrials.gov