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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Pain
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-17
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Written Informed Consent given by the patient
2. Male and female patients aging from 18 to 70
3. 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
4. The pain intensity score upon screening is at least 4 cm in VAS score

Exclusion Criteria:

1. 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
2. Frequent vomiting that might have prevented adequate absorption of the active ingredient after the film-coated tablet was taken
3. 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
4. Pregnancy and/or lactation or planned pregnancy
5. Known hypersensitivity to N-butylscopolammonium bromide
6. Alcohol or drug abuse
7. 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
8. Unwilling to or unable to complete the entire trial procedure according to the protocol
9. In investigator's opinion, the patient was not proper for the trial

Primary outcomes:
measure: Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
timeFrame: 3 days (1 day)
Secondary outcomes:
measure: Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)
timeFrame: Up to 3 days.
measure: Global Assessment of Efficacy by Patient on 4-point Scale
timeFrame: Post 3 days of treatment.
measure: Number of Patients With Adverse Events
timeFrame: Up to 3 days.
measure: Global Assessment of Tolerability by Investigator on a 4-point Scale
timeFrame: Day 3.
measure: Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
timeFrame: Up to 3 days.
measure: Percentage of Event for Time to Therapeutic Effect
timeFrame: 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.
Other outcomes:
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