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ATL-104:

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 With Chemotherapy and Peripheral Blood Stem Cell Transplant (PBSCT)

Further Study Details:
Primary Outcomes: Safety: Adverse events; Efficacy: Oral mucositis scale
Secondary Outcomes: Safety: Laboratory monitoring, vital signs, ECG; Pharmacokinetics of ATL-104
Expected Total Enrollment: 60
Study start: July 2004
Last follow-up: December 2005

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.
Eligibility

Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:

Patients with haematological malignancies undergoing chemotherapy in association with PBSCT
Exclusion Criteria:

Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
Visible oral disease
Significantly reduced platelet and neutrophil count
Location Information


United Kingdom
Addenbrooke's Hospital, Cambridge, United Kingdom

John Radcliffe Hospital, Headington, Oxford, United Kingdom

Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom

University of Wales College of Medicine, Cardiff, United Kingdom

Leiceser Royal Infirmary, Leicester, United Kingdom

Guy's Hospital London, London, United Kingdom

Derriford Hospital, Plymouth, United Kingdom

St James University Hospital, Leeds, United Kingdom


Study chairs or principal investigators

Robert Marcus, Principal Investigator, Addenbrooke's Hospital, Cambridge, UK
More Information

Study ID Numbers: ATL-104/034/CL
Last Updated: December 8, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00163280
Health Authority: United Kingdom: Department of Health