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NCT01506154

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Topical Patch in the Treatment of Pain Due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of Shoulder

Completed Phase 3 Last updated 12 January 2018
What this trial tests

Phase 3 trial testing MRX-7EAT in Bursitis in 210 participants. Completed in 1 October 2012.

Timeline
1 December 2011
Primary endpoint
1 October 2012
1 October 2012

Quick facts

Lead sponsorMEDRx USA, Inc.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment210
Start date1 December 2011
Primary completion1 October 2012
Estimated completion1 October 2012
Sites27 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

MEDRx USA, Inc. — full company profile →

Who can join

14 and older, any sex, with Bursitis or Tendonitis. 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.

Sponsor's own description

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Efficacy, Tolerability and Safety of MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of the Shoulder.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Advances toward transformative therapies for tendon diseases.
    Freedman BR, Mooney DJ, Weber E. · · 2022 · cited 28× · PMID 36070365 · DOI 10.1126/scitranslmed.abl8814

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