NCT00385515

Efficacy of SNX-1012 in the Treatment of Oral Mucositis

A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of SNX-1012 in Reducing the Duration and Severity of Ulcerative Oral Mucositis in Patients Receiving Cytotoxic Chemotherapy for Breast or Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Mucosal Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Stomatitis
• Oral Mucositis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-05-01
• Completion: 2008-07-01
• First posted: 2006-10-09
• Last updated: 2009-05-07
• Results posted: 2009-03-18

Locations

27 sites across 2 countries: United States, India