Clinical Trial: Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomised Double-Blind Placebo-Controlled Study of Orally Administered ATL-104 to Assess Safety, Tolerance and Effect on Oral Mucositis in Patients Following Treatment Wi
Brief 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 Summary: 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.
Sponsor: Alizyme
Current Primary Outcome:
- Safety: Adverse events [ Time Frame: 28 days post-treatment ]
- Efficacy: Oral mucositis scale [ Time Frame: 28 days post-treatment ]
Original Primary Outcome:
- Safety: Adverse events
- Efficacy: Oral mucositis scale
Current Secondary Outcome:
- Safety: Laboratory monitoring, vital signs, ECG [ Time Frame: 28 days post-treatment ]
- Pharmacokinetics of ATL-104
Original Secondary Outcome:
- Safety: Laboratory monitoring, vital signs, ECG
- Pharmacokinetics of ATL-104
Information By: Alizyme
Dates:
Date Received: September 9, 2005
Date Started: July 2004
Date Completion:
Last Updated: February 11, 2008
Last Verified: February 2008