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The objective of this study is to evaluate dry mouth relief in subjects with self-reported feeling of dry mouth after using an experimental mouth rinse or a positive control compared to a water control.
This is a controlled, randomized, 3-treatment, parallel study for subjects with self-reported dry mouth symptoms as determined by an Oral Examination and subject responses to the Dry Mouth Inventory (DMI) questionnaire (see section 12) at the Acclimation visit. Qualified subjects will be randomly assigned to one of three treatments at the Baseline visit. Safety will be assessed by Oral Examinations at Baseline/Day1 and Day 8. Subjects will complete questionnaires before product use, immediately after product use (Day 1 only), and after 30 minutes, 1 hour, 2 hours, 4 hours and 6 hours of product use on Baseline/Day 1 and Day 8. The PPAQ II questionnaire will be completed on the morning of Day 8 (see study schedule for details).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. |
|
| Water Control | Sham Comparator | Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. |
|
| Positive Control | Active Comparator | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dry mouth rinse | Device | relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | Product Performance and Attributes (PPAQ I) Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1) Relieves the discomfort of your dry mouth | 4-hours |
| Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | Product Performance and Attributes (PPAQ I) Since you have been using the product, please rate each of the following at this timepoint: (Select one response for attribute)- excellent=5, very good=4, good=3, fair=2, poor=1: 1) Relieves the discomfort of your dry mouth | 6-hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Milleman, DDS | Procter and Gamble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research | Fort Wayne | Indiana | 46825 | United States |
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Self-reported a dry mouth feeling according to the modified DMI questions (Subject must have answered at least 2 out of 4 questions below with 'agree a little,' 'agree' or 'strongly agree'):
How much do you agree or disagree that you experience the following? (strongly disagree, disagree, disagree a little, agree a little, agree, strongly agree)
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| ID | Title | Description |
|---|---|---|
| FG000 | Water Control | Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. Water Control: negative control |
| FG001 | Experimental Mouth Rinse | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
| FG002 | Positive Control | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Water Control | Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. Water Control: negative control |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | Product Performance and Attributes (PPAQ I) Since you have been using the product, please rate each of the following at this timepoint: (Select one response for 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 | score on a scale | 4-hours |
|
Products were used over 8 days
investigator/examiner observed
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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 Control | Water will be used as a mouth rinse and can be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using water, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. Water Control: negative control |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mouth injury | Injury, poisoning and procedural complications | MedDRA (10.0) | 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 | May 1, 2020 | Mar 8, 2021 | Prot_SAP_000.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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| Water Control | Other | negative control |
|
| BG001 | Experimental Mouth Rinse | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
| BG002 | Positive Control | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Experimental Mouth Rinse |
dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
| OG002 | Positive Control | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. |
|
|
| Primary | Response to "Relieving the Discomfort of Dry Mouth" From the Modified PPAQ I 4- and 6-hours Post-use on Day 1 of Treatment | Product Performance and Attributes (PPAQ I) Since you have been using the product, please rate each of the following at this timepoint: (Select one response for 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 | score on a scale | 6-hours |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 3 |
| 46 |
| EG001 | Experimental Mouth Rinse | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. | 0 | 45 | 0 | 45 | 2 | 45 |
| EG002 | Positive Control | dry mouth rinse to be taken up to 5x a day, at least twice a day, 15 ml for 30 seconds for a week. Subjects will be restricted from using mouth rinse, acclimation products, eating or drinking for 6-hours after first use (at-home) on Day 1 and Day 8. There are no eating or drinking restrictions Day 2-Day 7. dry mouth rinse: relieves dry mouth symptoms by physically coating oral mucosal surfaces. | 0 | 46 | 0 | 46 | 2 | 46 |
| Aphthous Stomatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
PI agreed to not publish results without prior written consent of Sponsor.