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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The purpose of the clinical trial is to evaluate and validate the performance of the experimental mouth spray when used by persons with mild to severe dry mouth symptoms.
The purpose of this study is to investigate the efficacy of 3M Dry Mouth Moisturizing Spray to reduce symptoms of dry mouth for up to 4 hours and after 7 days of use. In addition, this study aims to support comparative claims.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M Dry Mouth Moisturizing Spray | Experimental | Dry mouth agent |
|
| Biotene Moisturizing Mouth Spray | Active Comparator | Dry mouth agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray | Device | 20 ml bottle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 10 cm Mouth Dryness Visual Analog Score | Primary endpoint will be paired-difference in Visual Analog Scale (VAS) between experimental and active control product. On the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms. | 15 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 10 cm Mean Mouth Dryness Visual Analog Score | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 240 minutes post dose |
| 10 cm Mouth Dryness Visual Analog Score |
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Inclusion Criteria:
Screening - Start of Wash-In Visit
Water Only Evaluation Visit
Baseline Period 1/Randomization Visit
Exclusion Criteria:
Subject Exclusion Criteria for Start of Wash-In, Water Only Evaluation and Baseline Period 1 (Randomization Visit)
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| Name | Affiliation | Role |
|---|---|---|
| Yiming Li, DDS,MSD,PhD | Loma Linda University, School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University, School of Dentistry | Loma Linda | California | 92350 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3M Dry Mouth Moisturizing Spray Then Biotene Moisturizing Mouth Spray | Dry Mouth Agent: 3M Dry Mouth Moisturizing Spray: 20 ml bottle or Dry Mouth Agent: Biotene Moisturizing Mouth Spray: 44 ml bottle |
| FG001 | Biotene Moisturizing Mouth Spray Then 3M Dry Mouth Moisturizing Spray | Dry mouth agent: Biotene Moisturizing Mouth Spray: 44 ml bottle or Dry mouth agent: 3M Dry Mouth Moisturizing Spray: 20 ml bottle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: 7 Days |
|
| ||||||||||||||||||
| Washout Period: at Least 2 Days |
| |||||||||||||||||||
| Period 2: 7 Days |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3M Spray Then Biotene Spray | 3M Dry Mouth Moisturizing Spray then Biotene Dry Mouth Moisturizing Spray |
| BG001 | Biotene Spray Then 3M Spray | Biotene Dry Mouth Moisturizing Spray then 3M Dry Mouth Moisturizing Spray |
| 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 | 10 cm Mouth Dryness Visual Analog Score | Primary endpoint will be paired-difference in Visual Analog Scale (VAS) between experimental and active control product. On the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms. | Intent to treat (ITT) with Group Means Imputation | Posted | Mean | Standard Deviation | cm | 15 minutes post dose |
|
For the entire 7 day treatment period for each study arm
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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 | 3M(TM) Dry Mouth Moisturizing Spray | Dry mouth agent 3M(TM) Dry Mouth Moisturizing Spray: 20 ml bottle Distilled water: 15 ml |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Ulceration | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Abdominal Skin Sore |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elaine Egging/Project Manger | 3M Health Care | 651-737-0263 | eegging@mmm.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 | Jul 11, 2019 | Sep 23, 2020 | 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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All subjects completing the wash-in procedures and meeting inclusion/exclusion criteria will undergo a pre-study 5-hour visit (the day before randomization) to assess the effect of water on their dry mouth symptoms. The subjects will return the next day for confirmation that inclusion/exclusion criteria and the wash-in procedures continue to be met or followed. Eligible subjects will be randomized at this baseline visit in a 1:1 ratio to one of two treatment orders: A->B (AB) or B->A (BA).
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| Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray | Device | 44.3 ml bottle |
|
Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.
| 240 minutes |
| 10 cm Mean Mouth Dryness Visual Analog Score | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 5 minutes |
| 10 cm Mean Mouth Dryness Visual Analog Scale | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 30 minutes |
| 10 cm Mean Mouth Dryness Visual Analog Scale | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 60 minutes |
| 10 cm Mean Mouth Dryness Visual Analog Scale | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | 120 minutes |
| 10 cm Mouth Dryness Visual Analog Scale | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | 5 minutes |
| 10 cm Mouth Dryness Visual Analog Scale | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | 15 minutes |
| 10 cm Mouth Dryness Visual Analog Scale | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | 30 minutes |
| 10 cm Mouth Dryness Visual Analog Score | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | 60 minutes |
| 10 cm Mouth Dryness Visual Analog Score | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | 120 minutes |
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 5 minutes |
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 15 minutes |
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 30 minutes |
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 60 minutes |
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 120 minutes |
| Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | 240 minutes |
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 5 minutes |
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 15 minutes |
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 30 minutes |
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 60 minutes |
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 120 minutes |
| Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 240 minutes |
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 5 minutes |
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 15 minutes |
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 30 minutes |
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 60 minutes |
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 120 minutes |
| Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 240 minutes |
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 5 minutes |
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 15 minutes |
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 30 minutes |
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 60 minutes |
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 120 minutes |
| Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 240 minutes |
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 5 minutes |
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 15 minutes |
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 30 minutes |
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 60 minutes |
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 120 minutes |
| Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | 240 minutes |
| 11488135 | Background | Guijarro Guijarro B, Lopez Sanchez AF, Hernandez Vallejo G. Treatment of xerostomia. A review. Med Oral. 2001 Jan-Feb;6(1):7-18. English, Spanish. |
| 15765951 | Background | Fontana M, Zunt S, Eckert GJ, Zero D. A screening test for unstimulated salivary flow measurement. Oper Dent. 2005 Jan-Feb;30(1):3-8. |
| 8626174 | Background | Andersson G, Johansson G, Attstrom R, Edwardsson S, Glantz PO, Larsson K. Comparison of the effect of the linseed extract Salinum and a methyl cellulose preparation on the symptoms of dry mouth. Gerodontology. 1995 Jul;12(1):12-7. doi: 10.1111/j.1741-2358.1995.tb00124.x. |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | 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 |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Currently using Dry Mouth Products | Count of Participants | Participants |
|
|
|
|
| Secondary | 10 cm Mean Mouth Dryness Visual Analog Score | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | Intent to Treat (ITT) with Group Means Imputation | Posted | Mean | Standard Deviation | cm | 240 minutes post dose |
|
|
|
| Secondary | 10 cm Mouth Dryness Visual Analog Score | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | Intent to Treat (ITT) with Group Means Imputation | Posted | Least Squares Mean | Standard Error | cm | 240 minutes |
|
|
|
| Secondary | 10 cm Mean Mouth Dryness Visual Analog Score | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | Intent to Treat (ITT) with Group Means Imputation | Posted | Mean | Standard Deviation | cm | 5 minutes |
|
|
|
| Secondary | 10 cm Mean Mouth Dryness Visual Analog Scale | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | Intent to Treat (ITT) with Group Means Imputation | Posted | Mean | Standard Deviation | cm | 30 minutes |
|
|
|
| Secondary | 10 cm Mean Mouth Dryness Visual Analog Scale | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | Intent to Treat (ITT) with Group Means Imputation | Posted | Mean | Standard Deviation | cm | 60 minutes |
|
|
|
| Secondary | 10 cm Mean Mouth Dryness Visual Analog Scale | Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms | Intent to Treat (ITT) with Group Means Imputation | Posted | Mean | Standard Deviation | cm | 120 minutes |
|
|
|
| Secondary | 10 cm Mouth Dryness Visual Analog Scale | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | Intent to Treat (ITT) with Group Means Imputation | Posted | Least Squares Mean | Standard Error | cm | 5 minutes |
|
|
|
| Secondary | 10 cm Mouth Dryness Visual Analog Scale | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | Intent to Treat (ITT) with Group Means Imputation | Posted | Least Squares Mean | Standard Error | cm | 15 minutes |
|
|
|
| Secondary | 10 cm Mouth Dryness Visual Analog Scale | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | Intent to Treat (ITT) with Group Means Imputation | Posted | Least Squares Mean | Standard Error | cm | 30 minutes |
|
|
|
| Secondary | 10 cm Mouth Dryness Visual Analog Score | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | Intent to Treat (ITT) with Group Means Imputation | Posted | Least Squares Mean | Standard Error | cm | 60 minutes |
|
|
|
| Secondary | 10 cm Mouth Dryness Visual Analog Score | Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water. | Intent to Treat (ITT) with Group Means Imputation | Posted | Least Squares Mean | Standard Error | cm | 120 minutes |
|
|
|
| Secondary | Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| Secondary | Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | Posted | Count of Participants | Participants | 15 minutes |
|
|
|
| Secondary | Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| Secondary | Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | Posted | Count of Participants | Participants | 60 minutes |
|
|
|
| Secondary | Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Response on Dry Mouth Relief | Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent | Posted | Count of Participants | Participants | 240 minutes |
|
|
|
| Secondary | Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| Secondary | Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 15 minutes |
|
|
|
| Secondary | Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| Secondary | Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 60 minutes |
|
|
|
| Secondary | Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Response to Effectively Lubricates the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 240 minutes |
|
|
|
| Secondary | Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| Secondary | Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 15 minutes |
|
|
|
| Secondary | Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| Secondary | Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 60 minutes |
|
|
|
| Secondary | Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Response to Feel Comfortable in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 240 minutes |
|
|
|
| Secondary | Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| Secondary | Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 15 minutes |
|
|
|
| Secondary | Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| Secondary | Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 60 minutes |
|
|
|
| Secondary | Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Response to Soothing in the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 240 minutes |
|
|
|
| Secondary | Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 5 minutes |
|
|
|
| Secondary | Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 15 minutes |
|
|
|
| Secondary | Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 30 minutes |
|
|
|
| Secondary | Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 60 minutes |
|
|
|
| Secondary | Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 120 minutes |
|
|
|
| Secondary | Response to Effectively Moistens the Mouth | 5 point ordinal scale 1 = Poor and 5 = Excellent | Posted | Count of Participants | Participants | 240 minutes |
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| 7 |
| 40 |
| EG001 | Biotene Moisturizing Mouth Spray | Dry mouth agent Biotene Moisturizing Mouth Spray: 44.3 ml bottle Distilled water: 15 ml | 0 | 39 | 0 | 39 | 7 | 39 |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypoesthesia Oral | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oral Discomfort | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oropharyngeal Pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Paresthesia Oral | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Salivary Hypersecretion | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
Not provided
| 2=Some/Good |
|
| 3=Very Good |
|
| 4=Significant/Excellent |
|
| 2=Some/Good |
|
| 3=Very Good |
|
| 4=Significant/Excellent |
|
| 2=Some/Good |
|
| 3=Very Good |
|
| 4=Significant/Excellent |
|
| 2=Some/Good |
|
| 3=Very Good |
|
| 4=Significant/Excellent |
|
| 2=Some/Good |
|
| 3=Very Good |
|
| 4=Significant/Excellent |
|
| 2=Some/Good |
|
| 3=Very Good |
|
| 4=Significant/Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|
| 3= Good |
|
| 4= Very Good |
|
| 5= Excellent |
|