NCT00574860

EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Oral Mucositis
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	EN3285	Oral rinse
DRUG	Placebo	Oral rinse
OTHER	Standard of care	This will be the therapy most commonly used the the institution treating the patient

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-12-17
• Last updated: 2013-09-20

Locations

2 sites across 1 country: United States