Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Abdominal Pain

Intervention / Treatment
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* Drug: Hyoscine Butylbromide - Tablet
* Drug: Hyoscine Butylbromide - Capsule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyoscine Butylbromide - Tablet<br> | Drug: Hyoscine Butylbromide - Tablet<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Hyoscine Butylbromide - Capsule<br> | Drug: Hyoscine Butylbromide - Capsule<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA | 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). | 3 days (1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS) | The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: How many times have the spasm-like pains occurred today? 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times. | Up to 3 days. | 
| Global Assessment of Efficacy by Patient on 4-point Scale | The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad). | Post 3 days of treatment. | 
| Number of Patients With Adverse Events | The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria. | Up to 3 days. | 
| Global Assessment of Tolerability by Investigator on a 4-point Scale | The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad). | Day 3. | 
| Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination | Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs). | Up to 3 days. | 
| Percentage of Event for Time to Therapeutic Effect | This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred. | 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. |