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Efficacy of SNX-1012 in the Treatment of Oral Mucositis

NCT00385515 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2009-05-07

Study results available
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Summary

Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT) regimens and by radiation to the head and neck. The purpose of this study is to determine the effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM) according to World Health Organization (WHO) criteria.

Conditions

Interventions

DRUG

SNX-1012 (meclocycline sulfosalicylate)

tablets to be dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days

DRUG

placebo

Tablets to be dissolved in water for oral swish and expectorate; placebo, 4 times daily for 10 days

Sponsors & Collaborators

  • Mucosal Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-05-31
Completion
2008-07-31

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00385515 on ClinicalTrials.gov