Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-07 @ 10:27 AM
Study NCT ID:
NCT00574860
Status:
TERMINATED
Last Update Posted:
2013-09-20
First Post:
2007-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer
Sponsor:
Endo Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 3, Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Patients With Head and Neck Cancer Receiving Chemoradiotherapy
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Additional research
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).
Detailed Description:
This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: