NCT04496167

Safety and Efficacy of EN3835 in Participants With Frozen Shoulder

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	EN3835	Collagenase clostridium histolyticum
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2020-07-29
• Primary completion: 2022-04-14
• Completion: 2022-04-14
• First posted: 2020-08-03
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

38 sites across 1 country: United States

Regulatory

• FDA-regulated drug study