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The objective of this pilot study is to determine if an experimental mouth rinse and a marketed dry mouth rinse are more effective in relieving dry mouth compared to water.
This is a controlled, randomized, 3-treatment, 3-period crossover study in subjects with self-reported dry mouth symptoms as determined by subject responses (as determined by the response to "relieving the discomfort of dry mouth" question from the modified Product Performance and Attributes Questionnaire I/ Moisturization and Dryness (PPAQ I/ MD)) compared to water. Subjects enrollment is based on the responses to the Dry Mouth Inventory (DMI). A sufficient number of volunteers will be screened to ensure enrollment of up to 30 subjects at Acclimation. Subjects who meet the eligibility criteria will continue into the treatment phase of the study. Safety will be assessed by Oral examinations at Baseline/Day1 and Day 4. Subjects will complete questionnaires at Baseline (before product use Day 1 only), after immediate use, 30 minutes, 1 hour, 2 hours, and 4 hours after supervised product use on Day 1 and Day 4 of each period. The PPAQ II questionnaire will be completed in the morning of Day 4 of each period. Subjects will be randomly assigned to treatment sequences at the Baseline visit of Period 1. The treatment and washout periods will be repeated until all three treatment periods have been completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed Mouth Rinse | Active Comparator | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4. |
|
| Experimental Mouth Rinse | Experimental | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4. |
|
| Water/Negative Control | Sham Comparator | subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed Dry Mouth Rinse | Device | relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 | Product Performance and Attributes (PPAQ I) Question #1: Since you have been used the product, please rate each of the following at this timepoint: (Select one response for each attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1) Relieves the discomfort of your dry mouth | 2-hour, Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malgorzata Klukowska, DDS | Procter and Gamble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Procter & Gamble | Mason | Ohio | 45040 | United States |
Subjects that qualified were randomized to one of six treatment sequences: ABC, ACB, BCA, BAC, CAB, or CBA. Subjects had at least a 3 day washout before Period 1 and in-between each period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Single-center, randomized 3-treatment, 3-periods cross-over study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | single-center, randomized 3-treatment, 3-period crossover study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Product Performance and Attributes (PPAQ I) Question #1: 2-hr at Day 4 | Product Performance and Attributes (PPAQ I) Question #1: Since you have been used the product, please rate each of the following at this timepoint: (Select one response for each attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1) Relieves the discomfort of your dry mouth | Posted | Least Squares Mean | Standard Error | units on a scale | 2-hour, Day 4 |
|
Adverse event data was collected for the entire duration of the study for each intervention, an average of 1 month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Water/Negative Control | subjects will swallow 15 ml of water (on-site). Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after water intake (on-site) on Day 1 and Day 4. Water control: negative control |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Procter & Gamble | 5136225362 | combs.cs@pg.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2019 | Dec 7, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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3-treatment crossover, with 4 days of use
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| Water control | Other | negative control |
|
| Experimental Dry Mouth Rinse | Device | relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Dry Mouth Inventory | subjects had to answer 2 of the 4 dry mouth inventory questions positively. How much do you agree or disagree that you experience the following? (strongly disagree, disagree, disagree a little, agree a little, agree, strongly agree)
| Count of Participants | Participants |
|
dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4.
Marketed Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces.
| OG002 | Experimental Mouth Rinse | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4. Experimental Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
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| 0 |
| 20 |
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | Marketed Mouth Rinse | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4. Marketed Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. | 0 | 19 | 0 | 19 | 3 | 19 |
| EG002 | Experimental Mouth Rinse | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 4-hours after first use (on-site) on Day 1 and Day 4. Experimental Dry Mouth Rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. | 0 | 19 | 0 | 19 | 2 | 19 |
| mouth injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| oral herpes | Infections and infestations | Non-systematic Assessment |
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| cheilitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Gingival Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Mouth Ulceration | Gastrointestinal disorders | Non-systematic Assessment |
|
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