Back to resultsStudy 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
Primary Purpose
Abdominal Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hyoscine Butylbromide - Tablet
Hyoscine Butylbromide - Capsule
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hyoscine Butylbromide - Tablet
Hyoscine Butylbromide - Capsule
Arm Description
Outcomes
Primary Outcome Measures
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").
Secondary Outcome Measures
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.
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).
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.
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).
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02242305
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2008 (Actual)
Primary Completion Date
July 20, 2009 (Actual)
Study Completion Date
July 20, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
302 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyoscine Butylbromide - Tablet
Arm Type
Experimental
Arm Title
Hyoscine Butylbromide - Capsule
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hyoscine Butylbromide - Tablet
Intervention Type
Drug
Intervention Name(s)
Hyoscine Butylbromide - Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
Description
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").
Time Frame
3 days (1 day)
Secondary Outcome Measure Information:
Title
Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)
Description
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.
Time Frame
Up to 3 days.
Title
Global Assessment of Efficacy by Patient on 4-point Scale
Description
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).
Time Frame
Post 3 days of treatment.
Title
Number of Patients With Adverse Events
Description
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.
Time Frame
Up to 3 days.
Title
Global Assessment of Tolerability by Investigator on a 4-point Scale
Description
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).
Time Frame
Day 3.
Title
Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
Description
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).
Time Frame
Up to 3 days.
Title
Percentage of Event for Time to Therapeutic Effect
Description
This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
Learn more about this trial
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
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