Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder)
NCT ID: NCT04680156
Last Updated: 2022-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
120 participants
OBSERVATIONAL
2020-12-17
2022-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EN3835
Previously treated with EN3835 in EN3835-210 or the pivotal phase 3 studies
Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies
No treatment to be administered - Observational only
Placebo
Previously treated Placebo in EN3835-210 or the pivotal phase 3 studies
Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies
No treatment to be administered - Observational only
Interventions
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Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies
No treatment to be administered - Observational only
Eligibility Criteria
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Inclusion Criteria
2. Be willing not to use pain medications for the duration of the study period and for 2 weeks prior to the Day 180 visit. Pain medications include but are not limited to: barbiturates, benzodiazepines, methadone, buprenorphine, opioids (e.g., codeine, heroin, hydrocodone, hydromorphone, morphine, oxycodone), and cannabis.
Note: NSAIDs (ibuprofen, etc.) are allowed.
3. Be willing to undergo MRI of the affected shoulder as required by the protocol.
4. Be able to read, understand, and independently complete patient reported outcome instruments in English.
5. Be willing and able to cooperate with the requirements of the study.
6. Be adequately informed and understand the nature and risks of the study and be able to provide consent.
Exclusion Criteria
2. Plans to receive (or received prior to Day 180) any invasive or minimally invasive (ie, steroid injections, shoulder manipulation, surgery, etc.) procedures to the affected shoulder during study participation.
Note: PT is allowed. Any PT received should be captured in the respective electronic case report form (eCRF).
3. Has any contraindications for MRI (implant containing metal, internal metallic object, permanent cosmetics/make-up/tattoos-with exemption of the area to be treated/reviewed, claustrophobia, syncope, low blood pressure, epilepsy, asthma, anemia, or sickle cell disease) as determined by the technologist, the radiologist, and/or investigator performing imaging.
4. Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Kang
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Endo Clinical Trial Site #16
Birmingham, Alabama, United States
Endo Clinical Trial Site #9
Mobile, Alabama, United States
Endo Clinical Trial Site #25
Tucson, Arizona, United States
Endo Clinical Trial Site #8
Encinitas, California, United States
Endo Clinical Trial Site #7
Huntington Beach, California, United States
Endo Clinical Trial Site #14
La Mesa, California, United States
Endo Clinical Trial Site #11
Pasadena, California, United States
Endo Clinical Trial Site #2
Clearwater, Florida, United States
Endo Clinical Trial Site #19
Fort Lauderdale, Florida, United States
Endo Clinical Trial Site #1
Tampa, Florida, United States
Endo Clinical Trial Site #4
Winter Park, Florida, United States
Endo Clinical Trial Site #26
Dalton, Georgia, United States
Endo Clinical Trial Site #20
Lawrenceville, Georgia, United States
Endo Clinical Trial Site #21
Newnan, Georgia, United States
Endo Clinical Trial Site #24
Stockbridge, Georgia, United States
Endo Clinical Trial Site #23
Oak Brook, Illinois, United States
Endo Clinical Trial Site #28
Oak Brook, Illinois, United States
Endo Clinical Trial Site #10
Stony Brook, New York, United States
Endo Clinical Trial Site #29
Durham, North Carolina, United States
Endo Clinical Trial Site #13
Dayton, Ohio, United States
Endo Clinical Trial Site #30
Altoona, Pennsylvania, United States
Endo Clinical Trial Site #12
Indiana, Pennsylvania, United States
Endo Clinical Trial Site #5
State College, Pennsylvania, United States
Endo Clinical Trial Site #6
Bedford, Texas, United States
Endo Clinical Trial Site #17
Bellaire, Texas, United States
Endo Clinical Trial Site #27
Georgetown, Texas, United States
Endo Clinical Trial Site #22
Laredo, Texas, United States
Endo Clinical Trial Site #15
Plano, Texas, United States
Endo Clinical Trial Site #18
Plano, Texas, United States
Endo Clinical Trial Site #3
Danville, Virginia, United States
Countries
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Other Identifiers
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EN3835-223
Identifier Type: -
Identifier Source: org_study_id