Clinical Evaluation of MucoPEG™ for Xerostomia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SunBio, Inc.
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Change in VAS for Mouth Dryness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have read, understood and signed an informed consent prior to entering the study.
- •Must be 18 years of age or older
- •Good general and mental health with, in the opinion of the investigator or their medically qualified designee, no clinically relevant or significant abnormalities found on examination of the oral cavity or in their medical history.
- •Participant with a Challacombe Scale score of 1 or higher
- •Participant agrees not to eat, drink, chew tobacco, chew gum, smoke, brush or floss their teeth for 2 hours prior to study visits
- •Participant agrees not to use any oral care products or any type of breath mint or lozenges for 2 hours prior to study visits
- •Participant agrees not to consume any food or liquid during the study visits, except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
- •Participant agrees to using clinical oral care supplies provided by the investigators and no other products during the entire study
- •Understands and is willing and able to comply with all study procedures and restrictions
排除标准
- •Women who are pregnant or intending to become pregnant over the course of the study, or who are found to have a positive urine pregnancy test at the Screening Visit
- •Women who are breast-feeding
- •Participant is currently undergoing radiotherapy and/or chemotherapy.
- •Any condition the investigator identifies that may impede the participant's ability to properly participate in the study. For example, Alzheimer's Disease
- •Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study. For example, presence of oral ulceration.
- •Evidence of gross intra-oral neglect or need for extensive dental therapy
- •Denture wearer (complete dentures)
- •Participant on systemic parasympathetic medications (e.g. pilocarpine) for treating dry mouth, but the dose requirement of which is unstable
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or to any of their stated ingredients
- •Participation in another clinical study (including studies of cosmetic products) or in receipt of an investigational drug within 14 days of the screening visit
- •Previous participation in this study
- •Recent history (within one year prior to screening visit) of alcohol or other substance abuse
结局指标
主要结局
Change in VAS for Mouth Dryness
时间窗: baseline and 2 weeks, value at 2weeks minus value at baseline
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).
Dry Mouth Relief Questionnaires (DMRQ)
时间窗: 2 weeks(at last visit)
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.
Change in VAS for Tongue Dryness
时间窗: baseline and 2 weeks, value at 2weeks minus value at baseline
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).
次要结局
- Number of Participants With Treatment-related Adverse Events as Evaluated by the Principal Investigator(2 weeks)
- Dry Mouth Inventory (DMI) Questionnaire.(2 weeks)