ACTRN12619000593134已完成2 期
A Multi-centre, Double-blind, Randomised Study of the Safety and Efficacy of Orally-applied LBS-020 in Patients with Moderate to Severe Radiation-induced Xerostomia with a History of Previously-treated Head and Neck Cancer
ubris LLC0 个研究点目标入组 37 人开始时间: 2019年4月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Diagnosis of radiation-induced xerostomia
- •2. History of treated head and neck cancer with no evidence of active cancer
- •3. At least 6 months from last cancer treatment
- •4. A score >= 40 on a 100mm VAS assessing the subject’s mouth dryness (anchors: not dry at all; very dry)
- •5. Age 18 years or older
排除标准
- •1. Evidence of an active oral infection
- •2. History or presence of oral surface disorders not related to dry mouth
- •3. Use of any oral topical medication other than the study medications for the treatment of oral diseases including artificial saliva during the study period
- •4. History of any oral surgery within 180 days prior to the screening visit. Oral surgery will not be allowed during the study treatment period and elective oral surgery procedures should not be planned during the duration of the follow-up period.
- •5. Presence or history of any oral or systemic disorder or condition that might significantly hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trial procedures
- •6. Known hypersensitivity to one of the components of the study or procedural medications
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