NCT04680156

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)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-12-17
• Primary completion: 2022-09-12
• Completion: 2022-09-12
• First posted: 2020-12-22
• Last updated: 2022-12-30

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study