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

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)

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

Study Overview

• Status: Terminated
• Conditions: Adhesive Capsulitis; Frozen Shoulder
• Intervention / Treatment: Drug: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Endo Clinical Trial Site #16
    • Mobile, Alabama, United States, 36609
      • Endo Clinical Trial Site #9
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Endo Clinical Trial Site #25
  • California
    • Encinitas, California, United States, 92024
      • Endo Clinical Trial Site #8
    • Huntington Beach, California, United States, 92647
      • Endo Clinical Trial Site #7
    • La Mesa, California, United States, 91942
      • Endo Clinical Trial Site #14
    • Pasadena, California, United States, 91105
      • Endo Clinical Trial Site #11
  • Florida
    • Clearwater, Florida, United States, 33765
      • Endo Clinical Trial Site #2
    • Fort Lauderdale, Florida, United States, 33318
      • Endo Clinical Trial Site #19
    • Tampa, Florida, United States, 33606
      • Endo Clinical Trial Site #1
    • Winter Park, Florida, United States, 32789
      • Endo Clinical Trial Site #4
  • Georgia
    • Dalton, Georgia, United States, 30720
      • Endo Clinical Trial Site #26
    • Lawrenceville, Georgia, United States, 30043
      • Endo Clinical Trial Site #20
    • Newnan, Georgia, United States, 30265
      • Endo Clinical Trial Site #21
    • Stockbridge, Georgia, United States, 30281
      • Endo Clinical Trial Site #24
  • Illinois
    • Oak Brook, Illinois, United States, 60523
      • Endo Clinical Trial Site #23
    • Oak Brook, Illinois, United States, 60523
      • Endo Clinical Trial Site #28
  • New York
    • Stony Brook, New York, United States, 11794
      • Endo Clinical Trial Site #10
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Endo Clinical Trial Site #29
  • Ohio
    • Dayton, Ohio, United States, 45432
      • Endo Clinical Trial Site #13
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Endo Clinical Trial Site #30
    • Indiana, Pennsylvania, United States, 15701
      • Endo Clinical Trial Site #12
    • State College, Pennsylvania, United States, 16801
      • Endo Clinical Trial Site #5
  • Texas
    • Bedford, Texas, United States, 76021
      • Endo Clinical Trial Site #6
    • Bellaire, Texas, United States, 77401
      • Endo Clinical Trial Site #17
    • Georgetown, Texas, United States, 78628
      • Endo Clinical Trial Site #27
    • Laredo, Texas, United States, 78041
      • Endo Clinical Trial Site #22
    • Plano, Texas, United States, 75075
      • Endo Clinical Trial Site #15
    • Plano, Texas, United States, 75093
      • Endo Clinical Trial Site #18
  • Virginia
    • Danville, Virginia, United States, 24541
      • Endo Clinical Trial Site #3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

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 participant to be unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ASES composite score in affected shoulder	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	Days 180, 270, and 360

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): September 12, 2022
• Study Completion (Actual): September 12, 2022

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: EN3835-223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No