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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IL Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01506154
First received: January 5, 2012
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Bursitis
Tendonitis
Shoulder Pain
Drug: MRX-7EAT
Phase 3

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

Resource links provided by NLM:


Further study details as provided by IL Pharma Inc.:

Primary Outcome Measures:
  • Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Therapy with placebo
Drug: MRX-7EAT
Once daily application of a patch for 14 days
Experimental: MRX-7EAT
Therapy with experimental drug
Drug: MRX-7EAT
Once daily application of a patch for 14 days

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506154

  Show 27 Study Locations
Sponsors and Collaborators
IL Pharma Inc.
Investigators
Study Chair: Yuji Kuwabara IL Pharma
  More Information

No publications provided

Responsible Party: IL Pharma Inc.
ClinicalTrials.gov Identifier: NCT01506154     History of Changes
Other Study ID Numbers: MRX-7EAT-2006
Study First Received: January 5, 2012
Last Updated: October 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by IL Pharma Inc.:
bursitis/tendonitis and/or subdeltoid bursitis

Additional relevant MeSH terms:
Bursitis
Shoulder Pain
Tendinopathy
Joint Diseases
Musculoskeletal Diseases
Arthralgia
Pain
Signs and Symptoms
Muscular Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014