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Completed

NCT Number: NCT00163280

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

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

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Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Birmingham, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Safety: Adverse events

    Time frame: 28 days post-treatment

  2. Efficacy: Oral mucositis scale

    Time frame: 28 days post-treatment

Secondary outcomes

  1. Safety: Laboratory monitoring, vital signs, ECG

    Time frame: 28 days post-treatment

  2. Pharmacokinetics of ATL-104

Sponsors and collaborators

Lead sponsor

Alizyme

Industry

Registry information

Official study title

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)

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Feb 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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