Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04680156
Status:
TERMINATED
Last Update Posted:
2022-12-30
First Post:
2020-12-17
Brief Title:
Long-term Follow-up Durability Efficacy Study of EN3835 for the Treatment of AC of the Shoulder Frozen Shoulder
Sponsor:
Endo Pharmaceuticals
Organization:
Endo Pharmaceuticals
Study Overview
Official Title:
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
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None