Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-13-10-011648 | Other Identifier | EUDAMED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation (hyposialia) induced by chronic drug intake.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cross-over | Experimental | Four periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tested product : DC161-DP0291 | Device | Application of product in the mouth twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Observed area under the curve of dry mouth evaluations | Dry mouth will be self-rated using item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale questions. | 11 points : from baseline (before application) and up to 4 hours after the first product application |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erfurt | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tested product : DC161-DP0292 |
| Device |
Application of product in the mouth twice daily |
|
| Tested product : DC161-DP0293 | Device | Application of product in the mouth twice daily |
|
| Reference product: solution for oromucosal sprays | Device | Application of product in the mouth twice daily |
|
| ID | Term |
|---|---|
| D014987 | Xerostomia |
| D009059 | Mouth Diseases |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided