Condition category
Digestive System
Date applied
05/09/2005
Date assigned
16/09/2005
Last edited
20/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Marcus

ORCID ID

Contact details

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

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 measures

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

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

http://www.alizyme.com

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

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18997832

Publication citations

  1. 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.

Additional files

Editorial Notes