EUCTR2008-008512-51-DE进行中（未招募）不适用
A double blind, randomized, placebo-controlled, three-arm, phase II study to investigate the safety and efficacy of oral glycyrrhizin (Glycyron® tablets) for the treatment of gingivitis - Glycyron
onepharm Research & Development GmbH0 个研究点开始时间: 2009年3月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult male and female patients (aged 18 to 40 years)
- •Patients with gingivitis or mild periodontitis
- •Patients who have at least 4 teeth with GI = 1.5 per tooth at baseline
- •Patients with at least 20 teeth excluding the wisdom teeth
- •Patients must have read, understood and signed the informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with systemic diseases
- •Patients chronically taking medication except contraceptives
- •Patients with moderate and severe periodontitis
- •Patients treated (more than 2 days) with antibiotics, steroidal and non-steroidal antiphlogistics less than 4 weeks prior to the baseline examination and/or such a treatment planned for the duration of the trial
- •Patients chronically treated with topical steroids
- •Patients who smoke or have been smoking more than 5 cigarettes a day during the last 6 months
- •Patients with known hypersensitivity or allergy to the test product and its ingredients, especially licorice, or to medications that have a similar chemical structure
- •Patients with hypertension (BP =139/89 mm Hg)
- •Patients with serum potassium values out of normal range (3.8 – 5.2 mmol/l)
- •Patients with serum sodium values out of normal range (136 -152 mmol/l)
- •Patients with clinically relevant signs of edema
- •Patients with known 11ß-HSD deficiency (syndrome of apparent mineralcorticoid excess)
- •Patients who regularly consume glycyrrhizin or licorice containing products (e.g. confectionary, teas, …)
- •Patients who have participated in another clinical study less than 4 weeks prior to the baseline examination
- •Female patients who are pregnant or breast feeding
- •Female patients of childbearing potential except those fulfilling the following criteria:
- •a.Post-menopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH >40mlU/ml)
- •b.Post-surgery (6 weeks after bilateral ovarectomy with or without hysterectomy)
- •c.Regular and correct use of contraceptives with a PEARL Index of < 1% (e.g. implants, depot formulations of hormones, oral contraceptives, intra uterine device – IUD)
- •d.Sexual abstinence
- •e.Partner who had vasectomy
- •Patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study,
- •Patients can be excluded at the principal investigators discretion
研究者
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