Safety and Efficacy of EN3835 in Participants With Frozen Shoulder

NCT04496167 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: EN3835-210
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 38

Brief Summary

This study will evaluate the safety and efficacy of EN3835 for the treatment of adhesive capsulitis of the shoulder (frozen shoulder).

Conditions

Adhesive Capsulitis; Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95

  Adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from 0 (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying total score for 10 items by 5 and then dividing it by 3, score range of 0 (no function) to 50 (full function). Adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score), score range of 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.

  Baseline, Day 95

Secondary Outcomes (30)

• Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder

  Baseline, Days 22, 43, 64, and 95

• Change From Baseline in PROM for Internal Rotation in the Affected Shoulder

  Baseline, Days 22, 43, 64, and 95

• Change From Baseline in PROM for External Rotation in the Affected Shoulder

  Baseline, Days 22, 43, 64, and 95

• Change From Baseline in PROM for Abduction in the Affected Shoulder

  Baseline, Days 22, 43, 64, and 95

• Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder

  Baseline, Days 22, 43, 64, and 95

Study Arms (2)

EN3835

EXPERIMENTAL

EN3835 up to 1.74 mg

Drug: EN3835

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EN3835 DRUG

Collagenase clostridium histolyticum

EN3835

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

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

You may qualify if:

• Have idiopathic unilateral adhesive capsulitis (also known as frozen shoulder).
• Have unaffected range of motion in the contralateral shoulder as determined by the investigator.
• Be willing to undergo x-ray and magnetic resonance imaging (MRI) of both affected and unaffected shoulder.
• Agree to participate in supervised, in-office physical therapy sessions and to complete home exercises at designated time points during the study.
• Agree to avoid general lifting and carrying during the study as instructed.
• Be able to read, understand, and independently complete participant reported outcome instruments in English.
• If female, be of non-childbearing potential (history of hysterectomy, bilateraloophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study (and for 28 days after any active treatment period for participant who early terminate). Acceptable forms of contraception include hormonal measures (oral contraceptive pills, contraceptive patch, contraceptive ring, and injections), intrauterine devices, double barrier method (condom plus diaphragm, condom or diaphragm plus spermicidal gel or foam), surgical sterilization of the male partner, and abstinence.
• If male with reproductive potential, agree to use effective contraception (abstinence, surgical sterilization \[vasectomy\], or condom with spermicide) with a female partner of child-bearing potential for the duration of the study (and for 28 days after any active treatment period for participant who early terminate).
• 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:

• Has a known allergy to collagenase or any other excipient of EN3835 or any other procedural medication (including local anesthetics).
• Has received treatment for adhesive capsulitis (in the timeframes outlined below) or is planning to receive any treatment (other than study treatment) for adhesive capsulitis at any time during the study in the affected shoulder, including but not limited to:
• Physical therapy or acupuncture within 2 weeks before the first injection of study treatment.
• Intra-articular or intrabursal injection(s) of lidocaine, suprascapular nerve blocks, or electroanalgesic and/or thermoanalgesic modalities within 1 month before the Screening Visit.
• Intra-articular or intrabursal injection(s) of corticosteroids within 8 weeks before the Screening Visit.
• Intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography within 3 months before the Screening Visit.
• Manipulation under anaesthesia at any time prior to the study.
• Surgery (including arthroscopic or open capsular release, capsulectomy, or capsulotomy) at any time prior to the study.
• Has any abnormalities/conditions in the affected shoulder that would be potentially confounding as determined by the central MRI review committee grading criteria.
• Has a prosthesis or replacement of right or left shoulder, elbow, wrist, and/or hand.
• Has systemic conditions (malignancy, hypertension, diabetes, thyroid disease, thrombosis, physical impairment, infection, significant medical condition) that restricts study participation.
• Has any contraindications for MRI (implant containing metal, internal metallic object, permanent cosmetics/make-up/tattoos, claustrophobia, anemia, uncontrolled hypertension, epilepsy, asthma, sickle cell disease) as determined by the technologist, the radiologist, and/or investigator performing the imaging, with exemption of the area to be treated/reviewed.
• Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except \<150 milligrams of aspirin daily), 7 days prior to first injection and for the duration of the study.
• Has received oral or parenteral steroids for any reason within 3 weeks before the Screening Visit.
• Has, at any time, received collagenase for the treatment of adhesive capsulitis (including participant who received treatment in Study AUX-CC-870 or AUX-CC-871).

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (38)

Endo Clinical Trial Site #38

Birmingham, Alabama, 32505, United States

Location

Endo Clinical Trial Site #24

Birmingham, Alabama, 35243, United States

Location

Endo Clinical Trial Site #9

Mobile, Alabama, 36609, United States

Location

Endo Clinical Trial Site #29

Tucson, Arizona, 85712, United States

Location

Endo Clinical Trial Site #12

Encinitas, California, 92024, United States

Location

Endo Clinical Trial Site #16

Huntington Beach, California, 92647, United States

Location

Endo Clinical Trial Site #18

La Mesa, California, 91942, United States

Location

Endo Clinical Trial Site #14

Pasadena, California, 91105, United States

Location

Endo Clinical Trial Site #37

Denver, Colorado, 80209, United States

Location

Endo Clinical Trial Site #33

Bradenton, Florida, 34209, United States

Location

Endo Clinical Trial Site #3

Clearwater, Florida, 33765, United States

Location

Endo Clinical Trial Site #32

Clermont, Florida, 34711, United States

Location

Endo Clinical Trial Site #13

DeLand, Florida, 32720, United States

Location

Endo Clinical Trial Site #1

Fort Lauderdale, Florida, 33316, United States

Location

Endo Clinical Trial Site #2

Tampa, Florida, 33606, United States

Location

Endo Clinical Trial Site #20

Winter Park, Florida, 32789, United States

Location

Endo Clinical Trial Site #34

Dalton, Georgia, 30720, United States

Location

Endo Clinical Trial Site #26

Lawrenceville, Georgia, 30043, United States

Location

Endo Clinical Trial Site #30

Newnan, Georgia, 30265, United States

Location

Endo Clinical Trial Site #28

Stockbridge, Georgia, 30281, United States

Location

Endo Clinical Trial Site #31

Oak Brook, Illinois, 60523, United States

Location

Endo Clinical Trial Site #35

New Orleans, Louisiana, 70121, United States

Location

Endo Clinical Trial Site #8

Lincoln, Nebraska, 68510, United States

Location

Endo Clinical Trial Site #10

Stony Brook, New York, 11794, United States

Location

Endo Clinical Trial Site #21

Durham, North Carolina, 27704, United States

Location

Endo Clinical Trial Site #36

Mooresville, North Carolina, 28117, United States

Location

Endo Clinical Trial Site #6

Dayton, Ohio, 45432, United States

Location

Endo Clinical Trial Site #11

Altoona, Pennsylvania, 16602, United States

Location

Endo Clinical Trial Site #7

Indiana, Pennsylvania, 15701, United States

Location

Endo Clinical Trial Site #5

State College, Pennsylvania, 16801, United States

Location

Endo Clinical Trial Site #17

Bedford, Texas, 76021, United States

Location

Endo Clinical Trial Site #19

Bellaire, Texas, 77401, United States

Location

Endo Clinical Trial Site #15

Fort Worth, Texas, 76104, United States

Location

Endo Clinical Trial Site #27

Georgetown, Texas, 78628, United States

Location

Endo Clinical Trial Site #25

Laredo, Texas, 78041, United States

Location

Endo Clinical Trial Site #23

Plano, Texas, 75075, United States

Location

Endo Clinical Trial Site #22

Plano, Texas, 75093, United States

Location

Endo Clinical Trial Site #4

Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Endo Pharmaceuticals

clinicaltrials@endo.com

800-462-3636

Study Officials

• Luis Ortega, MD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: July 29, 2020
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: September 13, 2023
• Results First Posted: September 13, 2023

Record last verified: 2023-08

Data Sharing

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

Locations

US (38)