NCT00163280

Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis

Randomised Double-Blind Placebo-Controlled Study of Orally Administered ATL-104 to Assess Safety, Tolerance and Effect on Oral Mucositis in Patients Following Treatment With Chemotherapy and Peripheral Blood Stem Cell Transplant (PBSCT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Alizyme · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT

Detailed description

Mucositis is a serious side effect of cancer therapy and Peripheral Blood Stem Cell Transplant (PBSCT) which requires appropriate and effective management. Mucositis is a condition in which there is inflammation and ulceration of the mouth, throat and gut caused by damage to the mucosal barrier induced by chemo- and radiotherapy. Symptoms include pain, nausea, abdominal cramping, and vomiting. This study will investigate whether ATL-104, when administered as a swallowable mouthwash, is safe and well tolerated in patients undergoing PBSCT and to investigate its potential to reduce the level of severity of mucositis associated with PBSCT.

Conditions

• Mucositis

Interventions

Type	Name	Description
DRUG	ATL-104	Daily does of ATL-104 (50,100 or 150mg) or placebo for 3 days prior to the start of chemotherapy and peripheral blood stem cell transplantation. Following stem cell transplantation patients received 3 further daily doses of ATL-104 (50, 100 or 150mg) or placebo.

Timeline

• Start date: 2004-07-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2005-09-14
• Last updated: 2008-02-12

Locations

8 sites across 1 country: United Kingdom