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)
| ISRCTN | ISRCTN68967559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68967559 |
| ClinicalTrials.gov number | NCT00163280 |
| Secondary identifying numbers | ATL-104/034/CL |
- Submission date
- 05/09/2005
- Registration date
- 16/09/2005
- Last edited
- 20/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Marcus
Scientific
Scientific
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Is ATL-104 safe and well tolerated and does it show evidence of efficacy in mucositis in patients undergoing PBSCT? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Aged 18 - 65 years 2. With haematological malignancies 3. Undergoing chemotherapy in association with PBSCT |
| Key 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 |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Alizyme (UK)
Industry
Industry
Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
| Phone | +44 (0)1223 896 000 |
|---|---|
| Medical.Information@alizyme.co.uk | |
| Website | http://www.alizyme.com |
Funders
Funder type
Industry
Alizyme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2009 | Yes | No |
