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Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder)

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ClinicalTrials.gov Identifier: NCT04680156
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
This is a long-term follow-up study to evaluate the safety and durability (efficacy) of response to EN3835 compared to placebo in subjects who were treated in EN3835-210 or the pivotal Phase 3 parent studies for the treatment of AC of the shoulder (frozen shoulder).

Condition or disease Intervention/treatment
Adhesive Capsulitis Frozen Shoulder Drug: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies

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Study Type : Observational
Estimated Enrollment : 646 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Double-blind (Sponsor Open), Long-term Study to Evaluate the Safety and Durability (Efficacy) of Response to EN3835 Compared to Placebo in the Treatment of Adhesive Capsulitis of the Shoulder (Frozen Shoulder)
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : January 2029
Estimated Study Completion Date : January 2029

Group/Cohort Intervention/treatment
EN3835
Previously treated with EN3835 in EN3835-210 or the pivotal phase 3 studies
Drug: 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
Drug: 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




Primary Outcome Measures :
  1. Change in ASES composite score in affected shoulder [ Time Frame: Days 180, 270, and 360 ]
    The change from Day 95/end of study (EOS) in the parent studies in the adapted American Shoulder and Elbow Society (ASES) composite score for the affected shoulder


Biospecimen Retention:   Samples With DNA
Whole Blood


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All participants that have completed the EN3835-210 study or the pivotal Phase 3 studies in which they were enrolled.
Criteria

Inclusion Criteria:

  1. Have been enrolled and completed the EN3835-210 or pivotal Phase 3 parent studies (for Study EN3835-223 eligibility, completed subjects are those who were assessed for safety and obtained ASES scores at Day 95/EOS Visit; does not include early terminated subjects).
  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:

  1. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc.) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the IRB/IEC.
  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 subject to be unsuitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04680156


Contacts
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Contact: Deanna Lutte 800-462-3636 clinicaltrials@endo.com
Contact: Davina Cupo 800-462-3636 clinicaltrials@endo.com

Locations
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United States, Florida
Endo Clinical Trial Site #2 Recruiting
Clearwater, Florida, United States, 33765
Endo Clinical Trial Site #1 Recruiting
Tampa, Florida, United States, 33606
United States, Virginia
Endo Clinical Trial Site #3 Recruiting
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Don D'Amico Endo Pharmaceuticals
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04680156    
Other Study ID Numbers: EN3835-223
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases