- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00163280
Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis
February 11, 2008 updated by: Alizyme
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)
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
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Birmingham, United Kingdom
- Research Site
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Cambridge, United Kingdom
- Research Site
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Cardiff, United Kingdom
- Research Site
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Leeds, United Kingdom
- Research Site
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Leicester, United Kingdom
- Research Site
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London, United Kingdom
- Research Site
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Oxford, United Kingdom
- Research Site
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Plymouth, United Kingdom
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 4
Placebo
|
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.
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Experimental: 1
ATL-104 50mg
|
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.
|
Experimental: 2
ATL-104 100mg
|
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.
|
Experimental: 3
ATL-104 150mg
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: Adverse events
Time Frame: 28 days post-treatment
|
28 days post-treatment
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Efficacy: Oral mucositis scale
Time Frame: 28 days post-treatment
|
28 days post-treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: Laboratory monitoring, vital signs, ECG
Time Frame: 28 days post-treatment
|
28 days post-treatment
|
Pharmacokinetics of ATL-104
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Marcus, Addenbrooke's Hospital, Cambridge, UK
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
February 12, 2008
Last Update Submitted That Met QC Criteria
February 11, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATL-104/034/CL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Salma Hesham ElhoufiRecruitingOral Mucositis (Ulcerative) Due to Radiation | Radiation-Induced Mucositis | Radiation MucositisEgypt
-
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-
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Catalysis SLCompletedMucositis OralRussian Federation
-
Galera Therapeutics, Inc.CompletedRadiation Induced Oral MucositisUnited States, Canada, Puerto Rico
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-
Hadassah Medical OrganizationCompletedChemotherapy Induced MucositisIsrael
-
Ghada zakiNot yet recruiting
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