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

This study has been completed.
Sponsor:
Collaborator:
MEDRx Co., Ltd.
Information provided by (Responsible Party):
IL Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01161615
First received: July 12, 2010
Last updated: June 28, 2012
Last verified: June 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 Tendonitis and Bursitis of the Shoulder.


Condition Intervention Phase
Acute Tendonitis
Bursitis
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 Etodolac-Lidocaine Topical Patch in the Treatment of Tendonitis and Bursitis of the Shoulder

Resource links provided by NLM:


Further study details as provided by IL Pharma Inc.:

Primary Outcome Measures:
  • Mean of all 24 Current Pain Intensity scores collected on Days 2 through 7 on a 0-10 NPRS. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Therapy with placebo
Drug: MRX-7EAT
Application of up to two patches for up to 7 days.
Experimental: MRX-7EAT
Therapy with experimental drug
Drug: MRX-7EAT
Application of up to two patches for up to 7 days.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01161615

  Show 35 Study Locations
Sponsors and Collaborators
IL Pharma Inc.
MEDRx Co., Ltd.
Investigators
Study Chair: Martine Francis IL Pharma
  More Information

No publications provided

Responsible Party: IL Pharma Inc.
ClinicalTrials.gov Identifier: NCT01161615     History of Changes
Other Study ID Numbers: MRX-7EAT-1006
Study First Received: July 12, 2010
Last Updated: June 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by IL Pharma Inc.:
tendonitis and/or bursitis of the shoulder
acute tendonitis and/or bursitis of the shoulder

Additional relevant MeSH terms:
Tendinopathy
Bursitis
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Joint Diseases

ClinicalTrials.gov processed this record on September 18, 2014