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Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder) | Clinical Trials | Clareo Health

TERMINATED

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)

NCT04680156•Endo Pharmaceuticals

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (30)

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

Key Dates

Start Date

December 17, 2020

Primary Completion Date

September 12, 2022

Completion Date

September 12, 2022

Last Updated

December 30, 2022

Enrollment

120

ACTUAL participants

Conditions

Adhesive CapsulitisFrozen Shoulder

Interventions

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

DRUG

Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment

NCT07368751

Frozen Shoulder

View study

RECRUITINGNA

Additional Effects of Thoracic Spine Mobilization Combined With Glenohumeral Joint Mobilization on Pain, Range of Motion, and Functional Disability in Adhesive Capsulitis

NCT07328295

Adhesive Capsulitis

View study

RECRUITINGPHASE3

Phase 3 Study of the Efficacy and Safety of MR Arthrography Using the NEMO-103 Injection in Patients With Known or Suspected Shoulder Joint Diseases

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Vagus Nerve Stimulation Effect in Frozen Shoulder Treatment

Additional Effects of Thoracic Spine Mobilization Combined With Glenohumeral Joint Mobilization on Pain, Range of Motion, and Functional Disability in Adhesive Capsulitis

Phase 3 Study of the Efficacy and Safety of MR Arthrography Using the NEMO-103 Injection in Patients With Known or Suspected Shoulder Joint Diseases

Additional Effects of Niel-asher Technique on Patients With Adhesive Capsulitis

Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

A Study to Determine the Safety and Efficacy of Bevacizumab Administered Via Injection Into the Shoulder Joint of Participants With Adhesive Capsulitis (Frozen Shoulder)