A Double-Blind, Placebo-Controlled, Cross Over Study Using a Latin Square Design to Evaluate the Safety, Tolerability, and Efficacy of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjogren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Quantitative and qualitative assessment of dry mouth
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of NGX267 in the improvement of decreased salivary flow associated with primary or secondary Sjögren's syndrome.
For each patient, the study includes four periods of treatment separated by a washout period that may range from 4 - 8 days according to patient and site discretion. Each treatment period includes two overnight stays in the clinic. One dose of study drug is taken during each treatment period
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
- Double
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 21 to 55 years, diagnosed with primary or secondary Sjögren's syndrome.
- •Patients with a complaint of dry mouth based upon difficulty in speaking, swallowing, a sensation of mouth or throat dryness, lip or tongue dryness, or a level of thirst of sufficient intensity for the patient to seek therapy.
- •Females of childbearing potential must not be at risk for pregnancy during the study. Females not of childbearing potential include postmenopausal and women who have been surgically sterilized.
- •Patients must not be in an acute phase of illness.
排除标准
- •Patients who have clinically significant reduction kidney function. cardiovascular abnormalities; lymphoma secondary to Sjögren's syndrome; pulmonary disease; the presence of enlarged salivary glands; physical closure of the salivary gland or known surgical procedure on the lacrimal punctum.
- •Patients with diagnoses of a current gastrointestinal (GI) disease that would be exacerbated by the use of cholinomimetics; a current and acute psychiatric disorder, acute iritis, narrow angle glaucoma, or retinal disease as determined by medical history and physical examination.
- •Patients who are otherwise judged inappropriate for inclusion in the study by the investigator
- •Patients who have received any experimental drugs or devices or participated in any clinical trial within 30 days prior to screening including participation in a previous NGX267 clinical trial.
- •Patients who are allergic to compounds that are similar to NGX267.
研究组 & 干预措施
1
Placebo capsules
干预措施: NGX267 (Drug)
2
2 capsules in the am of each treatment period
干预措施: NGX267 (Drug)
3
2 capsules in the am of each treatment period
干预措施: NGX267 (Drug)
4
2 capsules in am of each treatment period
干预措施: NGX267 (Drug)
结局指标
主要结局
Quantitative and qualitative assessment of dry mouth
时间窗: 36 days
次要结局
- Tolerability and safety of NGX267(36 days)