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| ID | Type | Description | Link |
|---|---|---|---|
| 00908 | Other Identifier | Funder | |
| 44528835 | Registry Identifier | ISRCTN Registry |
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| Name | Class |
|---|---|
| Lamellar Biomedical Ltd | INDUSTRY |
| University of Glasgow | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visco-ease | Experimental | Visco-ease is a suspension of multilamellar vesicles comprising lipids in ratios which mimic the lipidic composition of endogenous extra-alveolar lamellar bodies. Visco-ease is suspended in physiological saline (0.9% NaCl) to provide a final dose concentration of 19.6 mg/mL. Visco-ease is a white to off-white turbid suspension. The device under evaluation in this clinical investigation is Visco-ease at a concentration of 19.6 mg/mL. |
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| RIX-Placebo | Placebo Comparator | Physiological Saline (sodium chloride 0.9% (w/v) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visco-ease | Device | 19.6 mg/mL of LMS-611 |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in GRIX Score | The primary endpoint will compare change in GRIX scores from baseline to 6-week follow-up between the group treated with Visco-ease and the Placebo group. | From baseline (Visit 1) to end of treatment (Visit 7, after 6 weeks of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Paterson | Beatson West of Scotland Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beatson West of Scotland Cancer Centre | Glasgow | Lanarkshire | G12 0YN | United Kingdom |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Placebo | Device | Physiological Saline |
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