Effect of Single Dose Imipramine on the Urethral and Anal Sphincter in Healthy Women Measured With Urethral Pressure Reflectometry (UPR) and Anal Acoustic Reflectometry (AAR)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Urethral Opening Pressure (UOP)
研究概览
简要总结
A double-blinded, randomized, crossover study in healthy females with placebo and single dose imipramine 50 mg.
Primary objective: Does imipramine increase the tone of the external urethral sphincter? Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). UOP increases correlate with effect in treating stress urinary incontinence. Can imipramine treat stress urinary incontinence? Secondary objective: Does imipramine increase the tone of the anal sphincter? The opening pressure is measured with Anal Acoustic Reflectometry (AAR). The investigators also wish to establish the within-subject standard deviation for AAR to enable power calculations in future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Packaging, randomization and masking of investigational drugs (imipramine and placebo) by Region Hovedstadens Apothecary before delivery to investigator. Sealed envelope with participant ID and drug data will be opened after data analysis.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed consent form.
- •Non-smoker.
- •Age 18 to 55, both inclusive.
- •Normal weight: BMI 19.5 to 30.0 kg/m
- •Weight minimum 50 kg.
- •No breastfeeding.
- •No pregnancy during the study.
- •No other clinical trials during the study.
排除标准
- •Known allergy to imipramine or any of the other known constituents.
- •Medical history with significant cardiovascular, gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, genitourologic, dermatologic, psychiatric, neurologic or dermatologic disease, lung disease, kidney disease, malignant disease or other significant diseases as assessed by the investigator.
- •Medical history of urinary incontinence.
- •Infectious disease 1 week prior to study day 1 or study day
- •Clinically significant findings during the physical examination.
- •Pregnancy.
- •Heart rate < 40 or > 100 beats per minute. Mean systolic blood pressure > 140 mmHg or mean diastolic blood pressure > 90 mmHg (mean of the measures on the screening day).
- •Prescription, over the counter or herbal medication two weeks prior to study day 1 or study day
- •Excluding paracetamol and excluding oral contraceptives.
- •Smoking 3 months prior to study day 1 or study day
- •Alcohol abuse, meaning > 14 units (12 g alcohol) per week within three weeks prior to study day 1 or study day
- •Drug abuse 3 months prior to study day 1 or study day
- •Any condition as assessed by the investigator.
研究组 & 干预措施
Imipramine first
A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2
干预措施: Placebo Oral Tablet (Drug)
Imipramine first
A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2
干预措施: Imipramine Hydrochloride 25 MG (Drug)
Placebo first
A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2
干预措施: Placebo Oral Tablet (Drug)
Placebo first
A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2
干预措施: Imipramine Hydrochloride 25 MG (Drug)
结局指标
主要结局
Urethral Opening Pressure (UOP)
时间窗: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).
次要结局
- Anal Opening Pressure (AOP)(Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.)
研究者
Jonatan Kornholt
Resident doctor in the Department of Clinical Pharmacology
Bispebjerg Hospital