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Safety and Efficacy, Using Pain and Function Questionnaires, of EN3835 vs. Placebo in Participants With Frozen Shoulder

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ClinicalTrials.gov Identifier: NCT04496167
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:
This study will evaluate the safety and efficacy EN3835 for the treatment of Adhesive Capsulitis of the shoulder.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Frozen Shoulder Drug: EN3835 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double Blind, Placebo Controlled Study of the Safety and Efficacy of EN3835 for the Treatment of Adhesive Capsulitis of the Shoulder
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: EN3835
EN3835 up to 1.74mg.
Drug: EN3835
Collagenase clostridium histolyticum or placebo comparator

Placebo Comparator: Placebo
Placebo
Drug: EN3835
Collagenase clostridium histolyticum or placebo comparator




Primary Outcome Measures :
  1. Change from Baseline in the adapted ASES Composite Score for the affected shoulder [ Time Frame: Day 95 ]
    The adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: a pain subscale and a function subscale. The pain subscale is a single item, numeric rating scale about pain in the affected shoulder on the day of assessment. The 11-point numeric rating scale ranges from 0 (No pain at all) to 10 (Pain as bad as it can be). The function subscale consists of 10 activities of daily living where the participant is asked to indicate on a 4 point ordinal scale their ability to do the activity with the affected arm.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have idiopathic unilateral Adhesive Capsulitis (AC; also known as frozen shoulder).
  2. Have unaffected ROM in the contralateral shoulder as determined by the investigator.
  3. Be willing to undergo x-ray and MRI of both affected and unaffected shoulder.
  4. Agree to participate in supervised, in-office PT sessions and to complete home exercises at designated time points during the study.
  5. Agree to avoid general lifting and carrying during the study as instructed.
  6. Be able to read, understand, and independently complete participant reported outcome instruments in English.
  7. 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.
  8. 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).
  9. Be willing and able to cooperate with the requirements of the study.
  10. Be adequately informed and understand the nature and risks of the study and be able to provide consent .

Exclusion Criteria:

  1. Has a known allergy to collagenase or any other excipient of EN3835 or any other procedural medication (including local anesthetics).
  2. Has received treatment for AC (in the timeframes outlined below) or is planning to receive any treatment (other than study treatment) for AC at any time during the study in the affected shoulder, including but not limited to:

    • PT 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.
    • MUA at any time prior to the study.
    • Surgery (including arthroscopic or open capsular release, capsulectomy, or capsulotomy) at any time prior to the study.
  3. Has any abnormalities/conditions in the affected shoulder that would be potentially confounding as determined by the central MRI review committee grading criteria.
  4. Has a prosthesis or replacement of right or left shoulder, elbow, wrist, and/or hand.
  5. Has systemic conditions (malignancy, hypertension, diabetes, thyroid disease, thrombosis, physical impairment, infection, significant medical condition) that restricts study participation.
  6. 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.
  7. Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except <150 mg of aspirin daily), 7 days prior to first injection and for the duration of the study.
  8. Has received oral or parenteral steroids for any reason within 3 weeks before the Screening Visit.
  9. Has, at any time, received collagenase for the treatment of AC (including participant who received treatment in Study AUX-CC-870 or AUX-CC-871).
  10. Has received treatment with an investigational product within 30 days (or 5 half lives, whichever is longer) of the screening visit.
  11. Has received collagenase treatments (eg, Santyl® ointment and/or XIAFLEX/XIAPEX®) for any other indication within 30 days prior to study treatment administration, or is planning to be treated with collagenase (other than study treatment) at any time during the study.
  12. Has donated blood within 30 days prior to the Screening Visit or has plans to donate blood during the study.
  13. Has a corrected QT interval (QTc) of ≥ 450 ms for male participant or ≥ 470 ms for female participant on the screening electrocardiogram (ECG).
  14. 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.
  15. Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant's well-being, (eg, evidence of any significant hematological, endocrine, cardiovascular, respiratory, neurological, renal, hepatic, or gastrointestinal disease). If there is a history of such disease but the condition has been stable for more than 5 year(s) and is judged by the investigator not to interfere with the participant's participation in the study, the participant may be included, with the documented approval of the Medical Monitor.
  16. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496167


Contacts
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Contact: Amy Lovell 800-462-3636 ClinicalTrials@Endo.com
Contact: Davina Cupo 800-462-3636 ClinicalTrials@Endo.com

Locations
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Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Karen Kang Endo Pharmaceuticals
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04496167    
Other Study ID Numbers: EN3835-210
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases