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

NCT01161615 | Completed Phase 3

• 1 other identifier: MRX-7EAT-1006
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 35

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 Tendonitis and Bursitis of the Shoulder.

Conditions

Acute Tendonitis; Bursitis

Keywords

tendonitis and/or bursitis of the shoulder; acute tendonitis and/or bursitis of the shoulder

Outcome Measures

Primary Outcomes (1)

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

  7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Therapy with placebo

Drug: Placebo

MRX-7EAT

EXPERIMENTAL

Therapy with experimental drug

Drug: MRX-7EAT

Interventions

MRX-7EAT DRUG

Application of up to two patches for up to 7 days.

MRX-7EAT

Placebo DRUG

Application of up to two patches for up to 7 days.

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:

• 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").

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEDRx USA, Inc.: lead

Study Sites (35)

Unknown Facility

Chandler, Arizona, 85224, United States

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Phoenix, Arizona, 85050, United States

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North Little Rock, Arkansas, 72114, United States

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Chico, California, 95929, United States

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Mission Hills, California, 91345, United States

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Palm Springs, California, 92262, United States

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San Diego, California, 92120, United States

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Aurora, Colorado, 80014, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80239, United States

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Daytona Beach, Florida, 32114, United States

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Fort Lauderdale, Florida, 33334, United States

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Gulf Breeze, Florida, 32561, United States

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Orlando, Florida, 32804, United States

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West Palm Beach, Florida, 33409, United States

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Avon, Indiana, 46123, United States

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Fishers, Indiana, 46038, United States

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Franklin, Indiana, 46131, United States

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Greenfield, Indiana, 46140, United States

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Muncie, Indiana, 47304, United States

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Dubuque, Iowa, 52001, United States

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Dubuque, Iowa, 52002, United States

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Wichita, Kansas, 67206, United States

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Erlanger, Kentucky, 41018, United States

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Henderson, Nevada, 89052, United States

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Charlotte, North Carolina, 28207, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45246, United States

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Oklahoma City, Oklahoma, 73112, United States

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Georgetown, Texas, 78626, United States

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Lubbock, Texas, 79410, United States

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San Antonio, Texas, 78229, United States

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Temple, Texas, 76502, United States

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Riverton, Utah, 84065, United States

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Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Martine Francis

  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: July 12, 2010
• First Posted: July 13, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

US (35)