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

Adhesive Capsulitis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04680156
• Other study ID #: EN3835-223
• Status: Terminated
• Start date: December 17, 2020
• Est. completion date: September 12, 2022

Study information

• Verified date: December 2022
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: September 12, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Frozen Shoulder

Intervention

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

Locations

Country	Name	City	State
United States	Endo Clinical Trial Site #30	Altoona	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 #16	Birmingham	Alabama
United States	Endo Clinical Trial Site #2	Clearwater	Florida
United States	Endo Clinical Trial Site #26	Dalton	Georgia
United States	Endo Clinical Trial Site #3	Danville	Virginia
United States	Endo Clinical Trial Site #13	Dayton	Ohio
United States	Endo Clinical Trial Site #29	Durham	North Carolina
United States	Endo Clinical Trial Site #8	Encinitas	California
United States	Endo Clinical Trial Site #19	Fort Lauderdale	Florida
United States	Endo Clinical Trial Site #27	Georgetown	Texas
United States	Endo Clinical Trial Site #7	Huntington Beach	California
United States	Endo Clinical Trial Site #12	Indiana	Pennsylvania
United States	Endo Clinical Trial Site #14	La Mesa	California
United States	Endo Clinical Trial Site #22	Laredo	Texas
United States	Endo Clinical Trial Site #20	Lawrenceville	Georgia
United States	Endo Clinical Trial Site #9	Mobile	Alabama
United States	Endo Clinical Trial Site #21	Newnan	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 #11	Pasadena	California
United States	Endo Clinical Trial Site #15	Plano	Texas
United States	Endo Clinical Trial Site #18	Plano	Texas
United States	Endo Clinical Trial Site #5	State College	Pennsylvania
United States	Endo Clinical Trial Site #24	Stockbridge	Georgia
United States	Endo Clinical Trial Site #10	Stony Brook	New York
United States	Endo Clinical Trial Site #1	Tampa	Florida
United States	Endo Clinical Trial Site #25	Tucson	Arizona
United States	Endo Clinical Trial Site #4	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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