At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 81 enrolled

Drug / intervention

SNX-1012 (meclocycline sulfosalicylate) +1 moredrug

Likely dose

SNX-1012 (meclocycline sulfosalicylate) 30 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00385515

NCT00385515Phase 2Completed

Compare CT.gov

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

Mucosal Therapeutics·interventional·Posted Oct 9, 2006·Updated May 7, 2009

In Brief

A Phase 2 clinical trial evaluating SNX-1012 (meclocycline sulfosalicylate) and placebo for Stomatitis and Oral Mucositis. Completed, enrolled 81 participants across 27 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsStomatitis, Oral Mucositis

CountriesIndia, United States

Collaborators--

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2006

First PostedOct 2006

Primary CompletionMay 2008

Study CompletionJul 2008

TodayJul 2026

First PostedOct 9, 2006

Enrollment StartJun 1, 2006

Primary CompletionMay 1, 2008

Study CompletionJul 1, 2008

TodayJul 2, 2026

Enrollment to primary: 1.9 yearsPosted 19.7 years ago

Interventions

SNX-1012 (meclocycline sulfosalicylate)drug

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

placebodrug

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