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

Mucositis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163280
• Other study ID #: ATL-104/034/CL
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: February 11, 2008
• Start date: July 2004
• Est. completion date: December 2005

Study information

• Verified date: February 2008
• Source: Alizyme
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mucositis
• Stomatitis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	London
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
Alizyme

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Adverse events		28 days post-treatment	Yes
Primary	Efficacy: Oral mucositis scale		28 days post-treatment	No
Secondary	Safety: Laboratory monitoring, vital signs, ECG		28 days post-treatment	Yes
Secondary	Pharmacokinetics of ATL-104			No