Safety, Tolerability and Efficacy of ATL-104 in Oral Muco... | NCT00163280

Studies
Safety, Tolerability and Efficacy of ATL-104 in Oral Mucositis

NCT00163280

Sponsor

Alizyme

Status

Completed

Last Update Posted

Feb 12, 2008Estimated

Enrollment

63Actual

Phase

Phase 2

Conditions

Mucositis

Interventions

ATL-104

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2008

Last Update Posted Date

Feb 12, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	ATL-104 50mg	Drug: ATL-104
2	Experimental	ATL-104 100mg	Drug: ATL-104
3	Experimental	ATL-104 150mg	Drug: ATL-104
4	Placebo Comparator	Placebo	Drug: ATL-104

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATL-104	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: Adverse events		28 days post-treatment
Efficacy: Oral mucositis scale		28 days post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Safety: Laboratory monitoring, vital signs, ECG		28 days post-treatment
Pharmacokinetics of ATL-104

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Marcus	Addenbrooke's Hospital, Cambridge, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham			United Kingdom
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D052016	Mucositis

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided