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A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain

NCT02100670 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2018-01-12

Study results available
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Summary

This Phase III pivotal efficacy study will assess efficacy and onset of pain relief of MFC51123 gel vs. placebo and MFC51123 gel vs. 1% diclofenac gel and 3% menthol gel in participants with an ankle sprain to support topical MFC51123 gel registration.

Conditions

Interventions

DRUG

1% diclofenac sodium plus 3% menthol

To be applied four times daily for 10 days.

DRUG

1% diclofenac sodium plus 0.09% menthol

To be applied four times daily for 10 days.

DRUG

3% menthol

To be applied four times daily for 10 days.

DRUG

Placebo with 0.09% menthol gel

To be applied four times daily for 10 days.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-01
Primary Completion
2015-03-01
Completion
2015-03-22

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02100670 on ClinicalTrials.gov