MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder

Phase 3

Completed

• Conditions: Acute Tendonitis; Bursitis
• Interventions: Drug: Placebo; Drug: MRX-7EAT

• Registration Number: NCT01161615
• Lead Sponsor: MEDRx USA, Inc.

Brief Summary

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 Tendonitis and Bursitis of the Shoulder.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2010-07-12
• Study First Posted: 2010-07-13
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Disposition First Submitted: 2012-06-28
• Disposition First Submitted QC: 2012-06-28
• Disposition First Posted: 2012-07-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-14
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Subject is 14 years of age or older (with assent according to state law).
• Females of child bearing potential must have a negative pregnancy test.
• Subject has a diagnosis of acute tendonitis or bursitis of one shoulder with the onset of the current episode 5 days and ≤ 21 days preceding the screening visit. Diagnosis is indicated by a positive Hawkins Test and Neer Test, both resulting in pain with motion and the existence of shoulder impingement related to tendonitis or bursitis.
• Subject has a Current Pain Intensity rated prior to study entry ≥ 5 but ≤ 8 on a Numeric Pain Rating Scale (NPRS) (11 point; range 0 to 10; anchors to be "none" and "severe").

Main

Exclusion Criteria

• Subject has a suspected tear in the rotator cuff, calcific tendonitis.
• Standard of Care (SOC) diagnosis with an AP and lateral x-ray, adhesive capsulitis, shoulder fractures, bilateral tendonitis or bursitis of the shoulders; or orthopedic surgical treatment is required.
• Subject has a positive Drop Arm Test indicative of a suspected tear; a positive O'Brien's Test suggestive of a glenoid labral tear; a positive Apprehension Test which would be indicative of glenohumeral instability.
• Subject had a previous episode of shoulder pain in the same area within two months.
• Subject received passive physical therapy treatments (e.g., deep heat or ultrasound) for the tendonitis/bursitis for the target shoulder within the past 24 hours; requires continued use of an immobilization device for treatment of the current episode of tendonitis or bursitis or use of iontophoresis.
• Subject has used oral pharmacologic treatment (NSAIDs or analgesic medications) less than 3 half-lives before the baseline assessments; ibuprofen is permitted prior to baseline as long as it is not within 6 hours of the baseline assessment.
• Subject has used any form of opioid within 24 hours of study entry or use of opioids for 5 or more consecutive days within the 30 days preceding enrollment.
• Subject has received systemic corticosteroids in the 30 days preceding the screening visit.
• Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or antidepressants.
• Subject used TNF alpha blockers or Class 1 anti-arrhythmic drugs within the past 60 days.
• Subject has a history or physical assessment finding of clinically significant.
• GI ulcers or abnormal bleeding, anemia, kidney disease, liver disease, poorly controlled lung, stomach, heart, or other vital organ disease as determined by the study investigator/physician.
• Subject has a history or physical assessment finding that is not compatible with safe participation in the study.
• Subject has a pain or medical problem that in the investigator's opinion may interfere with pain measurement of the target joint.
• Subject has active skin lesions or disease at the intended site of application of the study medication.
• Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives (e.g., adhesive tape).
• Subject has a history of prior failed treatment with topical NSAIDs.
• Subject has a history of drug or alcohol abuse.
• Subject received an investigational drug within a period of 30 days prior to receiving study medication.
• Subject is scheduled for elective surgery or other invasive procedures during the period of study participation.
• Subject is on workman's compensation or has pending legal hearings.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Therapy with placebo
MRX-7EAT	MRX-7EAT	Therapy with experimental drug

Primary Outcome Measures

Name	Time	Method
Mean of all 24 Current Pain Intensity scores collected on Days 2 through 7 on a 0-10 NPRS.	7 days