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| Name | Class |
|---|---|
| NAMSA | OTHER |
| Rudacure | INDUSTRY |
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The purpose of this study is to evaluate the effectiveness of the oral rinse comparing to MucoPEG™ and Biotene®.
This is a randomized open-label crossover study with 42 patients receiving treatment. Patients will be randomly assigned to receive either the MucoPEG™ or the Biotene® Dry Mouth Gentle Oral Rinse in the first period. Patients will use the assigned oral rinse two times a day for two weeks. Patients will switch to the other treatment after a wash-out period of one week.
The purpose of this study is to compare MucoPEG™ and it temporal change to those of the Biotene® Dry Mouth Gentle Oral Rinse in patients with Xerostomia. The study will gather data on patient reported outcomes on the safety and performance of the product, mouth-feel qualities and any changes in dry mouth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MucoPEG | Experimental | Arm being compared to against Biotene |
|
| Biotene | Active Comparator | Arm being compared against MucoPEG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MucoPEG | Device | Experimental |
| |
| Biotene |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VAS for Mouth Dryness | To demonstrate the effectiveness of MucoPEG is better than that of Biotene Dry Mouth Gentle Oral Rinse in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). (VAS), where 0 is "Not Dry at All" and 10 is "Very Dry" VAS (before), which is measured before using any of the products on the first day of each treatment period, at Visit 2 or Visit 5. VAS (end), which is measured after the last dose of a product on the final day of each treatment period, at Visit 4 or Visit 7. Change in the rating of mouth dryness is the difference between the two time points, that is, VAS (end) - VAS (before). | baseline and 2 weeks, value at 2weeks minus value at baseline |
| Dry Mouth Relief Questionnaires (DMRQ) | The effect of MucoPEG™ in relieving xerostomia, relative to that of Biotène was assessed using the Dry Mouth Relief Questionnaires (DMRQ). This questionnaire was given to the patients to answer the following question: "Does the product relieve the discomfort of dry mouth?" To answer the question, only one of the answer options is selected: 1. None/ (No Relief), 2. Not Enough, 3. Some/ Good, 4. Very Good, 5. Significant/ Excellent A favorable responses on the Dry Mouth Relief Questionnaire (DMRQ) include "4 - very good" or "5 - significant/excellent." The numbers are the number of patients who responded favorably at their last visit. | 2 weeks(at last visit) |
| Change in VAS for Tongue Dryness | To demonstrate the effectiveness of MucoPEG is better than that of Biotene Dry Mouth Gentle Oral Rinse in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). (VAS), where 0 is "Not Dry at All" and 10 is "Very Dry" VAS (before), which is measured before using any of the products on the first day of each treatment period, at Visit 2 or Visit 5. VAS (end), which is measured after the last dose of a product on the final day of each treatment period, at Visit 4 or Visit 7. Change in the rating of mouth dryness is the difference between the two time points, that is, VAS (end) - VAS (before). | baseline and 2 weeks, value at 2weeks minus value at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator | To evaluate the clinical safety of MucoPEG. Patient reported outcomes will be evaluated by the Principal Investigator. | 2 weeks |
| Dry Mouth Inventory (DMI) Questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| To be determined To be determined, DDS | Study Site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ColoradoENT | Colorado Springs | Colorado | 80923 | United States | ||
| Tufts University School of Dental Medicine |
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42 subjects were randomized. 3 subjects were not randomized. why the subjects (n = 3) exited the study early, were screen failure, withdrawal of consent, and lost of follow-up before randomization.
The study prospectively enrolled 45 subjects from 2 investigational sites across the USA starting 3 MAY 2022.
Twenty-two subjects were enrolled, with twenty-one completing the study at Tufts University School of Dental Medicine in Boston, MA, over approximately 42 days.
Twenty-three subjects were enrolled, with twenty-one completing the study at Colorado ENT & Allergy in Colorado Springs, CO.
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| ID | Title | Description |
|---|---|---|
| FG000 | MucoPEG First, Then Biotène® | Participants first used MucoPEG two times a day, once after breakfast and once before bedtime for 2 weeks. After a washout period of 1 weeks, they then used Biotene two times a day for 2 weeks. |
| FG001 | BIotene First, Then MucoPEG | Participants first used Biotene two times a day for 2 weeks. After a washout period of 1 weeks, they then used MucoPEG two times a day, once after breakfast and once before bedtime for 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention(2 Weeks) |
| |||||||||||||
| Second Intervention(2 Weeks) |
|
Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participant will be randomly allocated to either MucoPEG or Biotene in this crossover study in a 1:1 ratio. Participants first received MucoPEG or Biotene for 2 weeks. After a washout period of 1 weeks, they then received Biotene or MucoPEG for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in VAS for Mouth Dryness | To demonstrate the effectiveness of MucoPEG is better than that of Biotene Dry Mouth Gentle Oral Rinse in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). (VAS), where 0 is "Not Dry at All" and 10 is "Very Dry" VAS (before), which is measured before using any of the products on the first day of each treatment period, at Visit 2 or Visit 5. VAS (end), which is measured after the last dose of a product on the final day of each treatment period, at Visit 4 or Visit 7. Change in the rating of mouth dryness is the difference between the two time points, that is, VAS (end) - VAS (before). | Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2. | Posted | Mean | Standard Deviation | score on a scale | baseline and 2 weeks, value at 2weeks minus value at baseline |
Adverse event data were collected at treatment period (35days)
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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 | MucoPEG | Arm being compared to against Biotene MucoPEG: Experimental | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| celiac disease | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Min-Jung Ahn | Sunbio | +82-31-423-5467 | mjahn@sunbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2021 | Dec 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2023 | Dec 6, 2023 | 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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The study is a randomized, open-labelled crossover trial.
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| Device |
Active Comparator |
|
To demonstrate the effectiveness using the Dry Mouth Inventory (DMI). There are 8 Dry Mouth Inventory (DMI) questionaires as follows. 1. My mouth feels dry, 2. I have difficulty eating dry foods, 3. I get up at night to drink, 4. My mouth feels dry when eating a meal, 5. I sip liquids to aid in swallowing food, 6. I suck sweets or cough lollies to relieve dry mouth, 7. My lips stick to the teeth, 8. My tongue sticks to the roof of my mouth. Using a scale from "Disagree (0)" to "Strongly agree (3)". The scale has a minimum value of "0" and a maximum value of "24". The larger the scale, the more severe the dry mouth. |
| 2 weeks |
| Boston |
| Massachusetts |
| 02111 |
| United States |
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Challacombe Scale Score | The Challacombe Scale works as an additive score of 1 to 10. 1 being the least and 10 being the most severe. Each feature scores 1 and symptoms will not necessarily progress in the order shown, but summated scores indicate likely patient needs. Score changes over time can be used to monitor symptom progression or regression. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | MucoPEG | Arm being compared to against Biotene MucoPEG: Experimental |
| OG001 | Biotene | Arm being compared against MucoPEG Biotene: Active Comparator |
|
|
|
| Primary | Dry Mouth Relief Questionnaires (DMRQ) | The effect of MucoPEG™ in relieving xerostomia, relative to that of Biotène was assessed using the Dry Mouth Relief Questionnaires (DMRQ). This questionnaire was given to the patients to answer the following question: "Does the product relieve the discomfort of dry mouth?" To answer the question, only one of the answer options is selected: 1. None/ (No Relief), 2. Not Enough, 3. Some/ Good, 4. Very Good, 5. Significant/ Excellent A favorable responses on the Dry Mouth Relief Questionnaire (DMRQ) include "4 - very good" or "5 - significant/excellent." The numbers are the number of patients who responded favorably at their last visit. | Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2. | Posted | Number | participants response with 4 or 5 score | 2 weeks(at last visit) |
|
|
|
| Primary | Change in VAS for Tongue Dryness | To demonstrate the effectiveness of MucoPEG is better than that of Biotene Dry Mouth Gentle Oral Rinse in relieving xerostomia. Effectiveness will be addressed using the Visual Analogue Scale (VAS). (VAS), where 0 is "Not Dry at All" and 10 is "Very Dry" VAS (before), which is measured before using any of the products on the first day of each treatment period, at Visit 2 or Visit 5. VAS (end), which is measured after the last dose of a product on the final day of each treatment period, at Visit 4 or Visit 7. Change in the rating of mouth dryness is the difference between the two time points, that is, VAS (end) - VAS (before). | Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2. | Posted | Mean | Standard Deviation | score on a scale | baseline and 2 weeks, value at 2weeks minus value at baseline |
|
|
|
|
| Secondary | Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator | To evaluate the clinical safety of MucoPEG. Patient reported outcomes will be evaluated by the Principal Investigator. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Dry Mouth Inventory (DMI) Questionnaire. | To demonstrate the effectiveness using the Dry Mouth Inventory (DMI). There are 8 Dry Mouth Inventory (DMI) questionaires as follows. 1. My mouth feels dry, 2. I have difficulty eating dry foods, 3. I get up at night to drink, 4. My mouth feels dry when eating a meal, 5. I sip liquids to aid in swallowing food, 6. I suck sweets or cough lollies to relieve dry mouth, 7. My lips stick to the teeth, 8. My tongue sticks to the roof of my mouth. Using a scale from "Disagree (0)" to "Strongly agree (3)". The scale has a minimum value of "0" and a maximum value of "24". The larger the scale, the more severe the dry mouth. | Patients will be randomly allocated to either group A or group B in this crossover study in a 1:1 ratio. Patients in group A will begin using MucoPEG from Visit 2 for two weeks (period 1). This is followed by a washout period of one week. They will switch to using Biotène® Dry Mouth Gentle Oral Rinse from Visit 5 for another two weeks (period 2). Patients in group B will follow the same pattern except they receive Biotène® Dry Mouth Gentle Oral Rinse in period 1 and MucoPEG in period 2. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| 42 |
| 0 |
| 42 |
| 1 |
| 42 |
| EG001 | Biotene | Arm being compared against MucoPEG Biotene: Active Comparator | 0 | 42 | 0 | 42 | 2 | 42 |
| Food reaction | General disorders | Non-systematic Assessment |
|
| sinus infection | Infections and infestations | Non-systematic Assessment |
|
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| Period 2 |
|
|