DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: IL Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Tendonitis; Bursitis

Intervention: MRX-7EAT (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: IL Pharma Inc.

Official(s) and/or principal investigator(s):
Martine Francis, Study Chair, Affiliation: IL Pharma

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean of all 24 Current Pain Intensity scores collected on Days 2 through 7 on a 0-10 NPRS.

Eligibility

Minimum age: 14 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Main 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.

Locations and Contacts

Chandler, Arizona 85224, United States

Phoenix, Arizona 85050, United States

North Little Rock, Arkansas 72114, United States

Chico, California 95929, United States

Mission Hills, California 91345, United States

Palm Springs, California 92262, United States

San Diego, California 92120, United States

Aurora, Colorado 80014, United States

Colorado Springs, Colorado 80907, United States

Denver, Colorado 80239, United States

Daytona Beach, Florida 32114, United States

Ft. Lauderdale, Florida 33334, United States

Gulf Breeze, Florida 32561, United States

Orlando, Florida 32804, United States

West Palm Beach, Florida 33409, United States

Avon, Indiana 46123, United States

Fishers, Indiana 46038, United States

Franklin, Indiana 46131, United States

Greenfield, Indiana 46140, United States

Muncie, Indiana 47304, United States

Dubuque, Iowa 52001, United States

Dubuque, Iowa 52002, United States

Wichita, Kansas 67206, United States

Erlanger, Kentucky 41018, United States

Henderson, Nevada 89052, United States

Charlotte, North Carolina 28207, United States

Fargo, North Dakota 58103, United States

Cincinnati, Ohio 45246, United States

Oklahoma City, Oklahoma 73112, United States

Georgetown, Texas 78626, United States

Lubbock, Texas 79410, United States

San Antonio, Texas 78229, United States

Temple, Texas 76502, United States

Riverton, Utah 84065, United States

Danville, Virginia 24541, United States

Additional Information

Starting date: July 2010
Last updated: June 28, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017