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

NCT04680156 | Terminated FDA Drug

• 1 other identifier: EN3835-223
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 30

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 participants who were treated in EN3835-210 or the pivotal Phase 3 parent studies for the treatment of AC of the shoulder (frozen shoulder).

Conditions

Adhesive Capsulitis; Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies DRUG

No treatment to be administered - Observational only

EN3835; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).
• 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.
• Be willing to undergo MRI of the affected shoulder as required by the protocol.
• Be able to read, understand, and independently complete patient reported outcome instruments in English.
• Be willing and able to cooperate with the requirements of the study.
• Be adequately informed and understand the nature and risks of the study and be able to provide consent.

You may not qualify if:

• 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.
• 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).
• 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.
• Has any other conditions that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (30)

Endo Clinical Trial Site #16

Birmingham, Alabama, 35243, United States

Location

Endo Clinical Trial Site #9

Mobile, Alabama, 36609, United States

Location

Endo Clinical Trial Site #25

Tucson, Arizona, 85712, United States

Location

Endo Clinical Trial Site #8

Encinitas, California, 92024, United States

Location

Endo Clinical Trial Site #7

Huntington Beach, California, 92647, United States

Location

Endo Clinical Trial Site #14

La Mesa, California, 91942, United States

Location

Endo Clinical Trial Site #11

Pasadena, California, 91105, United States

Location

Endo Clinical Trial Site #2

Clearwater, Florida, 33765, United States

Location

Endo Clinical Trial Site #19

Fort Lauderdale, Florida, 33318, United States

Location

Endo Clinical Trial Site #1

Tampa, Florida, 33606, United States

Location

Endo Clinical Trial Site #4

Winter Park, Florida, 32789, United States

Location

Endo Clinical Trial Site #26

Dalton, Georgia, 30720, United States

Location

Endo Clinical Trial Site #20

Lawrenceville, Georgia, 30043, United States

Location

Endo Clinical Trial Site #21

Newnan, Georgia, 30265, United States

Location

Endo Clinical Trial Site #24

Stockbridge, Georgia, 30281, United States

Location

Endo Clinical Trial Site #23

Oak Brook, Illinois, 60523, United States

Location

Endo Clinical Trial Site #28

Oak Brook, Illinois, 60523, United States

Location

Endo Clinical Trial Site #10

Stony Brook, New York, 11794, United States

Location

Endo Clinical Trial Site #29

Durham, North Carolina, 27704, United States

Location

Endo Clinical Trial Site #13

Dayton, Ohio, 45432, United States

Location

Endo Clinical Trial Site #30

Altoona, Pennsylvania, 16602, United States

Location

Endo Clinical Trial Site #12

Indiana, Pennsylvania, 15701, United States

Location

Endo Clinical Trial Site #5

State College, Pennsylvania, 16801, United States

Location

Endo Clinical Trial Site #6

Bedford, Texas, 76021, United States

Location

Endo Clinical Trial Site #17

Bellaire, Texas, 77401, United States

Location

Endo Clinical Trial Site #27

Georgetown, Texas, 78628, United States

Location

Endo Clinical Trial Site #22

Laredo, Texas, 78041, United States

Location

Endo Clinical Trial Site #15

Plano, Texas, 75075, United States

Location

Endo Clinical Trial Site #18

Plano, Texas, 75093, United States

Location

Endo Clinical Trial Site #3

Danville, Virginia, 24541, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Karen Kang

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 22, 2020
• Study Start: December 17, 2020
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (30)