A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Hyoscine Butylbromide Capsule 10mg, to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets 10 mg (20mg, 3 Times Daily, Orally) Over a Period of 3 Days for the Treatment of Occasional or Recurrent Episodes of Self-reported Gastric or Intestinal Spasm-like Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 302
- 主要终点
- Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
研究概览
简要总结
In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent given by the patient
- •Male and female patients aging from 18 to 70
- •Subjects with occasional or recurrent episodes of gastric or intestinal spasm-like pain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has been present for at least 3 months
- •The pain intensity score upon screening is at least 4 cm in VAS score
排除标准
- •Patients with the following concomitant disease were not eligible for enrolment
- •Painful gastric or intestinal spasm of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance, gastritis, ulcer. Exception: diverticulitis and mild gastritis if dominant symptom was cramp pain, but ineligible if heartburn or reflux were dominant symptoms
- •Pain related with malignancy
- •Patients with other severe pain states of organic origin
- •Mechanical stenosis of the gastrointestinal tract, megacolon
- •Urinary retention associated with mechanical stenosis of urinary tract
- •Narrow-angled glaucoma
- •Tachyarrhythmia
- •Myasthenia gravis
- •Meulengracht-Gilbert syndrome
- •Known depression or known mental illness, anxiety disturbance
- •Frequent vomiting that might have prevented adequate absorption of the active ingredient after the film-coated tablet was taken
- •Patients taking the following concomitant medication are not eligible for enrolment
- •Analgesics
- •Spasmolytics
- •Anticholinergics
- •Affecting gastrointestinal motility, such as propantheline metoclopramide, cisapride, loperamide, diphenoxylate, opioid analgesics, antacids and other ulcer treatment
- •Regular administration of laxatives
- •Narcotics
- •Antidepressant treatment or treatment with psychoactive drugs
- •Pregnancy and/or lactation or planned pregnancy
- •Known hypersensitivity to N-butylscopolammonium bromide
- •Alcohol or drug abuse
- •Simultaneous participating in another clinical trial, or discontinuing from another clinical trial before randomization (administration of study medication); moreover, in the case of screening failure or premature discontinuing from the trial, repeated enrolment is forbidden
- •Unwilling to or unable to complete the entire trial procedure according to the protocol
- •In investigator's opinion, the patient was not proper for the trial
研究组 & 干预措施
Hyoscine Butylbromide - Tablet
干预措施: Hyoscine Butylbromide - Tablet (Drug)
Hyoscine Butylbromide - Tablet
干预措施: Placebo (Drug)
Hyoscine Butylbromide - Capsule
干预措施: Hyoscine Butylbromide - Capsule (Drug)
Hyoscine Butylbromide - Capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
时间窗: 3 days (1 day)
The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from "no pain" to "the most severe pain imaginable").
次要结局
- Global Assessment of Efficacy by Patient on 4-point Scale(Post 3 days of treatment.)
- Number of Patients With Adverse Events(Up to 3 days.)
- Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination(Up to 3 days.)
- Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)(Up to 3 days.)
- Global Assessment of Tolerability by Investigator on a 4-point Scale(Day 3.)
- Percentage of Event for Time to Therapeutic Effect(From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.)