Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00163280
Protocol/serial number
ATL-104/034/CL
Study information
Scientific title
Acronym
Study hypothesis
Is ATL-104 safe and well tolerated and does it show evidence of efficacy in mucositis in patients undergoing PBSCT?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Mucositis in the mouth and gastrointestinal tract
Intervention
ATL-104 (50 mg, 100 mg or 150 mg) or placebo, given as a swallowable mouth wash, as three single daily doses prior to commencement of PBSCT and three single daily doses following PBSCT.
Intervention type
Drug
Phase
Phase II
Drug names
ALT-104
Primary outcome measure
1. Safety: adverse events
2. Efficacy: oral mucositis scale
Secondary outcome measures
1. Safety parameters including laboratory monitoring, vital signs, electrocardiogram (ECG)
2. Pharmacokinetics of ATL-104
Overall trial start date
01/07/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 - 65 years
2. With haematological malignancies
3. Undergoing chemotherapy in association with PBSCT
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
01/07/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Alizyme (UK)
Sponsor details
Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
+44 (0)1223 896 000
Medical.Information@alizyme.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Alizyme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18997832
Publication citations
-
Results
Hunter A, Mahendra P, Wilson K, Fields P, Cook G, Peniket A, Crawley C, Hickling R, Marcus R, Treatment of oral mucositis after peripheral blood SCT with ATL-104 mouthwash: results from a randomized, double-blind, placebo-controlled trial., Bone Marrow Transplant., 2009, 43, 7, 563-569, doi: 10.1038/bmt.2008.363.