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

Alizyme

Status and phase: Completed; Phase 2

Conditions: Mucositis

Treatments: Drug: ATL-104

Study type: Interventional

Funder types: Industry

Identifiers

NCT00163280

ATL-104/034/CL

Details and patient eligibility

About

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

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

63 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

ATL-104 50mg

Treatment:

Drug: ATL-104

2

Experimental group

Description:

ATL-104 100mg

Treatment:

Drug: ATL-104

3

Experimental group

Description:

ATL-104 150mg

Treatment:

Drug: ATL-104

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: ATL-104