NL-OMON48000已完成不适用
INTERVENTION STUDY FOR THE RELIEF OF ORAL DRYNESS * NOVOSPRAY - INTERVENTION STUDY FOR THE RELIEF OF ORAL DRYNESS * NOVOSPRAY
Academisch Centrum Tandheelkunde Amsterdam (ACTA)0 个研究点目标入组 35 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
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
- 年龄范围
- 18 至 99（—）
入选标准
- •* Male or female, over 18 years of age, and capable of providing their written
- •informed consent.
- •* An unstimulated whole mouth salivary flow < 0.20 ml/min [8].
- •* Demonstrated moderate to severe level of dry mouth at screening, as indicated
- •by an XI-score of 25 or higher
- •* Diagnosis of Sjögren's syndrome.
- •* Access to internet.
排除标准
- •* Patients currently using a potassium-sparing diuretic antihypertensive drug
- •that contains amiloride; spironolactone (e.g.,Aldactone, Novo-Spiroton,
- •Spiractin, Spirtone, Verospiron or Berlactone); triamterene (e.g., Dyrenium);
- •or plerenone (e.g., Inspra). Chronic use of antihistamines will be permitted if
- •started at least 30 days before the start of the trial, and a stable dose is
- •maintained throughout the trial.
- •* Patients who started using systemic cholinergic secretagogues or tricyclic
- •antidepressant drugs within 12 weeks before screening, patients who are not on
- •a stable dosing regimen for at least 14 days prior to the screening visit, or
- •patients who are unable to maintain stable dosing throughout the study.
- •* Females who are pregnant or trying to become pregnant, or are nursing.
- •* Patients showing evidence of a significant active or ongoing oral infection
- •or other oral conditions (eg, lichen planus) that, in the opinion of the
- •Investigator, might affect the safety of the subject or be exacerbated during
- •study participation.
- •* Patients suffering from acute infections of the salivary glands.
- •* Patients with a present history of any clinically significant and
- •uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular,
- •psychological, pulmonary, metabolic, endocrine, or hematological disorder or
- •disease, or any other major disorder or disease, in the opinion of the
- •Investigator.
- •* Patients consuming more than 2 alcoholic drinks per day or with a significant
- •history of alcoholism or drug/chemical abuse within the past 12 months.
- •* Patients who have received an investigational drug within the past 30 days.
- •* Patients with a history of allergy to chicken egg proteins or food
- •preservatives
- •* Patients having an unstimulated whole mouth salivary flow > 0.20 ml/min.
- •* Patients who are incapable of filling out questionnaires because of cognitive
- •or physical inability
研究者
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