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

NCT04680156 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2022-12-30

No results posted yet for this study

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).

Conditions

  • Adhesive Capsulitis
  • Frozen Shoulder

Interventions

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

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Karen Kang · Endo Pharmaceuticals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2022-09-12
Completion
2022-09-12
FDA Drug
Yes

Countries

  • United States

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04680156 on ClinicalTrials.gov