跳至主要内容
临床试验/NCT00163280
NCT00163280已完成2 期

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)

Alizyme1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2004年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Safety: Adverse events

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with haematological malignancies undergoing chemotherapy in association with PBSCT

排除标准

  • Clinically significant conditions that would exclude the patient receiving chemotherapy in association with PBSCT
  • Visible oral disease
  • Significantly reduced platelet and neutrophil count

研究组 & 干预措施

1

Experimental

ATL-104 50mg

干预措施: ATL-104 (Drug)

2

Experimental

ATL-104 100mg

干预措施: ATL-104 (Drug)

3

Experimental

ATL-104 150mg

干预措施: ATL-104 (Drug)

4

Placebo Comparator

Placebo

干预措施: ATL-104 (Drug)

结局指标

主要结局

Safety: Adverse events

时间窗: 28 days post-treatment

Efficacy: Oral mucositis scale

时间窗: 28 days post-treatment

次要结局

  • Pharmacokinetics of ATL-104
  • Safety: Laboratory monitoring, vital signs, ECG(28 days post-treatment)

研究者

发起方
Alizyme
申办方类型
Industry

研究点 (1)

Loading locations...

相似试验