Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the Shoulder

NCT01506154 | Completed Phase 3

• 1 other identifier: MRX-7EAT-2006
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 27

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 Pain due to Recent Onset Supraspinatous and/or Subacromial Tendonitis/Bursitis and/or Subdeltoid Bursitis of the Shoulder.

Conditions

Bursitis; Tendonitis; Shoulder Pain

Keywords

bursitis/tendonitis and/or subdeltoid bursitis

Outcome Measures

Primary Outcomes (1)

• Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.

  7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Therapy with placebo

Drug: MRX-7EAT

MRX-7EAT

EXPERIMENTAL

Therapy with experimental drug

Drug: MRX-7EAT

Interventions

MRX-7EAT DRUG

Once daily application of a patch for 14 days

MRX-7EAT; Placebo

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEDRx USA, Inc.: lead

Study Sites (27)

Unknown Facility

Birmingham, Alabama, 35216, United States

Location

Unknown Facility

Scottsdale, Arizona, 85258, United States

Location

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

San Diego, California, 92120, United States

Location

Unknown Facility

Denver, Colorado, 80239, United States

Location

Unknown Facility

Clearwater, Florida, 33761, United States

Location

Unknown Facility

Coral Gables, Florida, 33134, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33136, United States

Location

Unknown Facility

Kissimmee, Florida, 34741, United States

Location

Unknown Facility

Lauderdale Lakes, Florida, 33319, United States

Location

Unknown Facility

Miami, Florida, 33155, United States

Location

Unknown Facility

Orlando, Florida, 32804, United States

Location

Unknown Facility

Boise, Idaho, 83702, United States

Location

Unknown Facility

Lexington, Kentucky, 40504, United States

Location

Unknown Facility

Marrero, Louisiana, 70072, United States

Location

Unknown Facility

Southfield, Michigan, 48034, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Fargo, North Dakota, 58103, United States

Location

Unknown Facility

Zanesville, Ohio, 43701, United States

Location

Unknown Facility

Gresham, Oregon, 97030, United States

Location

Unknown Facility

Altoona, Pennsylvania, 16602, United States

Location

Unknown Facility

Charleston, South Carolina, 29412, United States

Location

Unknown Facility

Dallas, Texas, 75254, United States

Location

Unknown Facility

El Paso, Texas, 79902, United States

Location

Unknown Facility

San Antonio, Texas, 78207, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Temple, Texas, 76502, United States

Location

MeSH Terms

Conditions

Bursitis; Tendinopathy; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuji Kuwabara

  IL Pharma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 9, 2012
• Study Start: December 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 16, 2018

Record last verified: 2012-10

Locations

US (27)