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A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy

NCT02687087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-02-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical safety and effectiveness of Visco-ease dry mouth spray for the treatment of Radiotherapy Induced Xerostomia (RIX) in head and neck cancer patients.

A parallel group double blind study design has been selected. The primary outcome is change in GRIX scores from baseline (visit 1) to end of treatment (visit 7). The primary outcome will be compared between Visco-ease and the placebo treatment.

Conditions

  • Xerostomia

Interventions

DEVICE

Visco-ease

19.6 mg/mL of LMS-611

DEVICE

Placebo

Physiological Saline

Sponsors & Collaborators

  • Lamellar Biomedical Ltd

    collaborator INDUSTRY

  • University of Glasgow

    collaborator OTHER

  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Claire Paterson · Beatson West of Scotland Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-24
Primary Completion
2017-02-02
Completion
2017-02-02

Countries

  • United Kingdom

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 NCT02687087 on ClinicalTrials.gov