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ZeroTolerance Mucositis: Managing Oral and Alimentary Mucositis With High Potency Sucralfate - ProThelial

NCT02016807 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2013-12-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

ProThelial

August 2013, the FDA cleared the use of ProThelial, a polymerized high potency sucralfate paste, as a device for the management of oral mucositis.Standard potency non-polymerized sucralfate is not recommended by MASCC/ISOO for the treatment or prevention of mucositis, oral or alimentary. However high potency polymerized sucralfate has been associated with rapid amelioration and prevention of both oral and alimentary mucositis in a patient with advanced head neck cancer treated simultaneously with high dose chemo-radiation. High potency sucralfate is standard sucralfate polymerized into 'sucralfate sheets' that adhere and orderly layer upon the mucosa achieving and maintaining elevated concentrations of sucralfate long after the initial dose administration. Three hours following administration, high potency sucralfate maintains a 7 fold greater surface concentration of sucralfate on normal lining and a 23 fold greater concentration on inflamed, ulcerated mucosa.

Sponsors & Collaborators

  • Ashley Downs Bioscience

    lead INDUSTRY

Principal Investigators

  • Ricky W McCullough, MD, MSc · Ashley Downs Bioscience (Translational Medicine Research)

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT02016807 on ClinicalTrials.gov