ISRCTN24654047终止未知
Pain relief of mouth ulcers with a barrier-forming gel, mouthwash, spray and patch containing hyaluronic acid: a prospective, randomised, controlled study versus standard of care (saline mouthwash)
Alliance Pharmaceuticals (United Kingdom)0 个研究点目标入组 52 人开始时间: 2021年8月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Able and willing to provide written informed consent and comply with study procedures
- •2. Healthy, male or female subjects aged =18 years old
- •3. Have an AU that began no more than 48 h prior to screening and is =2 mm and =10 mm in diameter
- •4. Have not more than six AU
- •5. Have a pain score =5.0 on the VAS at Screening without stimulus being applied
- •6. Fluent in the language of the study site and able to read in this language
- •7. Using a form of contraception with at least a 98% success rate when used correctly
排除标准
- •1. Have a known disorder or situation that causes mouth ulcers (including but not limited to connective tissue disorders and orthodontic devices)
- •2. Have a known allergy or known history of hypersensitivity to the components of the test device and/or related compounds
- •3. Clinically relevant abnormal medical history or physical findings at Screening that could interfere with the safety of the subject or objectives of the study
- •4. Have an oral disease, other than AU, that could interfere with the study
- •5. Have had oral surgery performed within 3 months prior to Screening
- •6. Have started taking medicines or using medical devices for the treatment of the outbreak of this AU
- •7. Ongoing pharmacological or device treatments that may interfere with the study (including but not limited to the use of herbal treatments, analgesics, antibiotics, and anti-inflammatories)
- •8. Use or intention to use any other topical treatments in the oral cavity or on the gums during the course of the study that might affect the study
- •9. Female subjects who are pregnant or breastfeeding
- •10. Female subjects who intend to conceive during the study
- •11. Drink more than 14 units of alcohol per week (female subjects) or more than 21 units per week of alcohol (male subjects) or who are not willing to abstain from alcohol during the period of the study
- •12. Do the following: smoke cigarettes, e-cigarettes, cigars or pipe, chew tobacco, use snuff or have used any of the aforementioned items within the last 3 months
- •13. Have a history of using drugs of abuse or have a positive test for drugs of abuse at the Screening visit
- •14. Subjects who, in the opinion of the Investigator, are not suitable for enrolment for another reason
研究者
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