DrugLib.com — Drug Information Portal

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



Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain 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: Bursitis; Tendonitis; Shoulder Pain

Intervention: MRX-7EAT (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: IL Pharma Inc.

Official(s) and/or principal investigator(s):
Yuji Kuwabara, 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 Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid 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 Topical Patch in the Treatment of Pain Due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of 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 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.

Eligibility

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

Criteria:

Inclusion Criteria:

- Females of child bearing potential must have a negative pregnancy test and be using

an adequate method of birth control.

- Subject has a diagnosis of acute supraspinatous or subacromial bursitis/tendonitis

and/or subdeltoid bursitis of one shoulder with the onset of the current episode ≥ 24 hours and ≤ 7 days preceding the screening visit.

- Subject has a Current Pain Intensity rated prior to study entry ≥ 6 but ≤ 8 on a

Numeric Pain Rating Scale (NPRS). Exclusion Criteria:

- Subject has a suspected tear in the rotator cuff, calcific tendonitis, adhesive

capsulitis, shoulder fractures, bilateral shoulder pain, bilateral tendonitis and/or bursitis of the shoulders, bicipital tendonitis; 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; a positive Yergason's Test which would be indicative of bicipital tendonitis.

- Subject had a previous episode of shoulder pain in the same area within two weeks

prior to the current episode; history of chronic pain in the target shoulder; history of rotator cuff injury or previous surgery in the same area.

- Subject received passive physical therapy treatments for the pain in the target

shoulder within the past 24 hours.

- Subject has used oral pharmacologic treatment less than 5 half-lives before the

baseline assessments.

- 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; or local injections such as intra-articular, bursal, peritendinous; topical corticosteroids are acceptable unless applied to the target joint; and inhaled or intranasal steroids acceptable (e. g., Flonase®).

- Subject recently initiated sleep medications, muscle relaxants, anticonvulsants or

antidepressants (within the past 30 days).

- 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 fibromyalgia, spondyloarthropathies (SpA) or other systemic arthritis

such as rheumatoid arthritis. Arthritis typically localized such as gout or osteoarthritis is acceptable as long as it does not affect the injured area.

- Subject has a painful syndrome (e. g. sciatica) or cervical spine disorder leading to

a nerve entrapment syndrome or other 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 study medication

application, which may be covered by the patch. Skin lesions include open wounds, rash, papules and vesicles; abrasions, lacerations or any break in skin.

- Subject has a history of allergy to etodolac, other NSAIDs, lidocaine or adhesives

(e. g., adhesive tape).

- Subject is scheduled for elective surgery or other invasive procedures during the

period of study participation.

Locations and Contacts

Birmingham, Alabama 35216, United States

Scottsdale, Arizona 85258, United States

Los Angels, California 90036, United States

San Diego, California 92120, United States

Denver, Colorado 80239, United States

Clearwater, Florida 33761, United States

Coral Gables, Florida 33134, United States

Fort Lauderdale, Florida 33136, United States

Kissimmee, Florida 34741, United States

Lauderdale Lakes, Florida 33319, United States

Miami, Florida 33155, United States

Orlando, Florida 32804, United States

Boise, Idaho 83702, United States

Lexington, Kentucky 40504, United States

Marrero, Louisiana 70072, United States

Southfield, Michigan 48034, United States

Raleigh, North Carolina 27612, United States

Fargo, North Dakota 58103, United States

Zanesville, Ohio 43701, United States

Gresham, Oregon 97030, United States

Altoona, Pennsylvania 16602, United States

Charleston, South Carolina 29412, United States

Dallas, Texas 75254, United States

El Paso, Texas 79902, United States

San Antonio, Texas 78207, United States

San Antonio, Texas 78229, United States

Temple, Texas 76502, United States

Additional Information

Starting date: December 2011
Last updated: October 24, 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