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Gelclair at Conditioning or After Oral Mucositis Diagnosed vs. Magic Mouth Wash in Stem Cell Transplant Recipients

NCT03490396 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-11-22

No results posted yet for this study

Summary

Patients receiving high-dose chemotherapy/conditioning prior to stem cell transplantation (SCT) are at high risk for developing painful lesions in the oral cavity, known as oral mucositis (OM).

In this high risk adult population, the study objectives are to investigate the efficacy and tolerability of Gelclair® (GEL; an FDA cleared medical device indicated for the management of painful oral lesions) and ideal timing of initiation of therapy (at the time of conditioning or after mild OM is diagnosed) for the management of oral mucositis (OM), relative to a commercially available compounded mouth wash (First® Mouthwash BLM "Magic Mouth Wash"; MMW) initiated after mild OM is diagnosed. The study may be adapted based on an interim analysis and recommendations of the interim data review committee.

Conditions

  • Oral Mucositis

Interventions

DEVICE

Gelclair

Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel

COMBINATION_PRODUCT

First® Mouthwash BLM

Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash

Sponsors & Collaborators

  • PharPoint Research, Inc.

    collaborator INDUSTRY

  • Midatech Pharma US Inc.

    lead INDUSTRY

Principal Investigators

  • Mary Kay Delmedico, PhD · Midatech Pharma US Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-15
Primary Completion
2019-11-15
Completion
2019-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03490396 on ClinicalTrials.gov