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

  • STATUS
    Recruiting
  • End date
    Jan 22, 2025
  • participants needed
    646
  • sponsor
    Endo Pharmaceuticals
Updated on 7 October 2022
frozen shoulder

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).

Details
Condition Adhesive Capsulitis, Frozen Shoulder
Treatment Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies
Clinical Study IdentifierNCT04680156
SponsorEndo Pharmaceuticals
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
Note: PT is allowed. Any PT received should be captured in the respective
electronic case report form (eCRF)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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