BursitisPhase 3NCT01506154
Safety & Efficacy Study of MRX-7EAT Patch in the Treatment of Pain of the Shoulder
A Phase 3 study testing MRX-7EAT in people with Bursitis and Tendonitis, run by MEDRx USA, Inc. at 27 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Bursitis, Tendonitis, Shoulder Pain
- What is being tested?
- MRX-7EAT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 27 sitesUnited States
- Study dates
- Dec 2011to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Study site
Altoona, Pennsylvania, 16602
Study site
Birmingham, Alabama, 35216
Study site
Boise, Idaho, 83702
Study site
Charleston, South Carolina, 29412
Study site
Clearwater, Florida, 33761
Study site
Coral Gables, Florida, 33134
Study site
Dallas, Texas, 75254
Study site
Denver, Colorado, 80239
Study site
El Paso, Texas, 79902
Study site
Fargo, North Dakota, 58103
Study site
Fort Lauderdale, Florida, 33136
Study site
Gresham, Oregon, 97030
Study site
Kissimmee, Florida, 34741
Study site
Lauderdale Lakes, Florida, 33319
Study site
Lexington, Kentucky, 40504
Study site
Los Angeles, California, 90036
Study site
Marrero, Louisiana, 70072
Study site
Miami, Florida, 33155
Study site
Orlando, Florida, 32804
Study site
Raleigh, North Carolina, 27612
Study site
San Antonio, Texas, 78207
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92120
Study site
Scottsdale, Arizona, 85258
Study site
Southfield, Michigan, 48034
Study site
Temple, Texas, 76502
Study site
Zanesville, Ohio, 43701
About this study
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
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
- Being tested
- MRX-7EAT
- Keywords
- bursitis/tendonitis and/or subdeltoid bursitis
- Medical subject headings
- Bursitis, Tendinopathy, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRX-7EATDrug
Once daily application of a patch for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Therapy with placebo Receives: Drug: MRX-7EAT |
| MRX-7EAT | Experimental | Therapy with experimental drug Receives: Drug: MRX-7EAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BursitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDRx USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuji Kuwabara, Study chair, IL Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506154
- Sponsor's protocol ID
- MRX-7EAT-2006
- Status last verified
- Oct 2012
- First submitted
- 5 Jan 2012
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01506154
- Acronym / sponsor ID
- MRX-7EAT-2006
- Conditions
- Bursitis, Tendonitis, Shoulder Pain
- Keywords
- bursitis/tendonitis and/or subdeltoid bursitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- MEDRx USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: MRX-7EATTherapy with placebo |
| MRX-7EAT | Experimental | Drug: MRX-7EATTherapy with experimental drug |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRX-7EATOnce daily application of a patch for 14 days | Drug | MRX-7EAT, Placebo |
Primary outcome
Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuji Kuwabara study chair
IL Pharma
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MRX-7EAT in people with Bursitis and Tendonitis, run by MEDRx USA, Inc. at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of all 16 Current Pain Intensity scores collected on Days 4 through 7 on a 0-10 NPRS. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.