ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial
Public ClinicalTrials.gov record NCT02016807. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Treatment and Prevention of Oral and Alimentary Mucositis Using Polymerized Cross-Linked High Potency Sucralfate as a Single Agent Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Polymerized (cross-linked) sucralfate malate paste (ProThelial) may be an effective single therapy approach for the management of chemoradiation mucositis, treating and preventing its occurrence in the oral cavity, esophagus, stomach, small and large intestine. PURPOSE: This observational multi-phase trial is studying how well polymerized (cross-linked) sucralfate malate paste (ProThelial) works to prevent and treat mucositis in adult patients who are to receive or have received chemo/radiation therapy that have caused or is anticipated to cause mucositis in the oral cavity, esophagus, stomach, small or large intestine. The Phase IV study addresses prevention and treatment in the oral cavity. The Phase I study addresses prevention and treatment in the esophagus, stomach, small and large intestine.
Study identification
- NCT ID
- NCT02016807
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 95 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2012
- Primary completion
- Dec 31, 2014
- Completion
- Dec 31, 2014
- Last update posted
- Dec 19, 2013
2013 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Translational Medicine Research Center | Foster | Rhode Island | 02825 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02016807, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 19, 2013 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02016807 live on ClinicalTrials.gov.