Trials / Completed
CompletedNCT02687087
A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy
Assessing the Safety and Effectiveness of Visco-ease for the Treatment of Radiotherapy Induced Xerostomia in Head and Neck Cancer Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- NHS Greater Glasgow and Clyde · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Visco-ease | 19.6 mg/mL of LMS-611 |
| DEVICE | Placebo | Physiological Saline |
Timeline
- Start date
- 2016-03-24
- Primary completion
- 2017-02-02
- Completion
- 2017-02-02
- First posted
- 2016-02-22
- Last updated
- 2017-02-20
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02687087. Inclusion in this directory is not an endorsement.