NCT01198834 is a Phase 3 clinical trial of MRX-7EAT in Ankle Sprains, sponsored by MEDRx USA, Inc..

Who is sponsoring NCT01198834?

NCT01198834 is sponsored by MEDRx USA, Inc..

What drugs are being tested in NCT01198834?

Interventions in NCT01198834: MRX-7EAT, Placebo, Lidocaine, Etodolac.

What condition does NCT01198834 study?

NCT01198834 studies Ankle Sprains.

Is NCT01198834 still recruiting?

NCT01198834 is currently completed. Last updated 14 January 2018.

Last reviewed 2018-01-14 · How we verify

NCT01198834

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Multi-Center, Double-Blind, Factorial, Comparator and Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains

Completed Phase 3 Last updated 14 January 2018

What this trial tests

Phase 3 trial testing MRX-7EAT in Ankle Sprains in 600 participants. Completed in 1 June 2011.

Timeline

1 September 2010

Primary endpoint
1 June 2011

1 June 2011

Quick facts

Lead sponsor	MEDRx USA, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	600
Start date	1 September 2010
Primary completion	1 June 2011
Estimated completion	1 June 2011
Sites	33 locations across United States

Drugs / interventions tested

MRX-7EAT — full drug profile →
Placebo
Lidocaine — full drug profile →
Etodolac (ETODOLAC) — full drug profile →

Conditions studied

Ankle Sprains — all drugs for Ankle Sprains →

Sponsor

MEDRx USA, Inc. — full company profile →

Who can join

14 and older, any sex, with Ankle Sprains. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mean of All Current Pain Intensity During Point and Flex Scores on Days 2 Through 7 on a 0-10 Numeric Pain Rating Scale (NPRS).
Time frame: Days 2 to 7

Sponsor's own description

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Ankle Sprains

Currently open trials in the same condition.

NCT06905418 — Design and Validation of a Mobile Health Application for Home-Based Musculoskeletal Therapy in Ankle Sprain · NA · active not recruiting
NCT06898554 — Spinal and Supraspinal Control in Chronic Ankle Instability · NA · recruiting
NCT05785533 — A Mobile Recovery Guidance App for Children and Young Adults With Acute Ankle Inversion Injuries · NA · recruiting
NCT06499935 — The Effect of Taping on Plantar Pressure Distribution in Players With Chronic Ankle Instability · NA · recruiting
NCT06631690 — Effect of ACL Reconstruction in Biomechanical Properties of Ankle Joint Complex · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01198834 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MEDRx USA, Inc.
Last refreshed: 14 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01198834.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing