- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242305
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
July 26, 2017 updated by: Boehringer Ingelheim
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
302
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyoscine Butylbromide - Tablet
|
|
Active Comparator: Hyoscine Butylbromide - Capsule
|
What is the study measuring?
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
Time Frame: 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").
|
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)
Time Frame: Up to 3 days.
|
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
Time Frame: Post 3 days of treatment.
|
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
Time Frame: Up to 3 days.
|
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
Time Frame: Day 3.
|
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
Time Frame: Up to 3 days.
|
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
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2008
Primary Completion (Actual)
July 20, 2009
Study Completion (Actual)
July 20, 2009
Study Registration Dates
First Submitted
September 16, 2014
First Submitted That Met QC Criteria
September 16, 2014
First Posted (Estimate)
September 17, 2014
Study Record Updates
Last Update Posted (Actual)
July 27, 2017
Last Update Submitted That Met QC Criteria
July 26, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Abdominal Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Antiemetics
- Gastrointestinal Agents
- Adjuvants, Anesthesia
- Mydriatics
- Scopolamine
- Butylscopolammonium Bromide
Other Study ID Numbers
- 202.838
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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