Phase II randomised, double-blind, placebo controlled, multicentre study of orally administered ATL-104 (by swallowable mouthwash) to assess safety and tolerance and effect on oral mucositis in patients with haematological malignancies after treatment with chemotherapy associated with peripheral blood stem cell transplant (PBSCT)
Completed
- Conditions
- Mucositis in the mouth and gastrointestinal tractDigestive SystemOther diseases of lip and oral mucosa
- Registration Number
- ISRCTN68967559
- Lead Sponsor
- Alizyme (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Aged 18 - 65 years
2. With haematological malignancies
3. Undergoing chemotherapy in association with PBSCT
Exclusion Criteria
1. Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
2. Visible oral disease
3. Significantly reduced platelet or neutrophil count
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method