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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at least 10 consecutive days beginning on day 1 of a chemotherapy cycle
Awards & highlights
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.
Eligible Conditions
- Mouth Sore
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at least 10 consecutive days beginning on day 1 of a chemotherapy cycle
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at least 10 consecutive days beginning on day 1 of a chemotherapy cycle
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Duration of Ulcerative Oral Mucositis
Secondary study objectives
Number of Participants With Ulcerative Oral Mucositis
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
SNX-1012 (meclocyline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg 4 times daily for 10 days
Group II: 2Placebo Group1 Intervention
placebo (matched to SNX-1012) tablets dissolved in water for oral swish and expectorate; 4 times daily for 10 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meclocycline
Not yet FDA approved
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Who is running the clinical trial?
Mucosal TherapeuticsLead Sponsor
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