Who is sponsoring NCT01968005?

NCT01968005 is sponsored by MEDRx USA, Inc..

What drugs are being tested in NCT01968005?

Interventions in NCT01968005: Etoreat®(Etodolac-Lidocaine Topical Patch), Placebo.

What condition does NCT01968005 study?

NCT01968005 studies Low Back Pain.

Is NCT01968005 still recruiting?

NCT01968005 is currently completed. Last updated 14 January 2018.

Last reviewed 2018-01-14 · How we verify

NCT01968005

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, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of Etoreat®(Etodolac-Lidocaine Topical Patch) in the Treatment of Acute Low Back Pain

Completed Phase 3 Last updated 14 January 2018

What this trial tests

Phase 3 trial testing Etoreat®(Etodolac-Lidocaine Topical Patch) in Low Back Pain in 232 participants. Completed in 1 November 2014.

Timeline

1 November 2013

Primary endpoint
1 May 2014

1 November 2014

Quick facts

Lead sponsor	MEDRx USA, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	232
Start date	1 November 2013
Primary completion	1 May 2014
Estimated completion	1 November 2014
Sites	7 locations across United States

Drugs / interventions tested

Etoreat®(Etodolac-Lidocaine Topical Patch) — full drug profile →
Placebo

Conditions studied

Low Back Pain — all drugs for Low Back Pain →

Sponsor

MEDRx USA, Inc. — full company profile →

Who can join

14 and older, any sex, with Low Back Pain. 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.

SPID (Summed pain intensity difference) from baseline over the pain assessments from Day 1 to Day 8
Time frame: 8 days

Sponsor's own description

The purpose of this study is to evaluate efficacy, tolerability and safety of Etoreat®(Etodolac-Lidocaine Topical Patch) in the treatment of acute low back pain (LBP).

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 Low Back Pain

Currently open trials in the same condition.

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NCT07535047 — Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain · NA · recruiting
NCT07463729 — Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome · NA · recruiting
NCT07250568 — Office Program Effects on Pain, Posture, Muscle Physiology, Stress, Ergonomics, and Quality of Life in LBP Workers · NA · recruiting
NCT07467070 — Effectiveness of Pilates on Postural Correction, Core Strength and Flexibility in Younger Individuals With Non-specific · 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 NCT01968005 (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/NCT01968005.

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