Phase 3
N=302
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
Abdominal Pain
Bottom Line
View on ClinicalTrials.gov: NCT02242305 ↗Enrolled (actual)
302
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA — -2.48; -2.45; -2.36; -2.31 Units on a scale — p=0.809
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hyoscine Butylbromide - Tablet (Drug); Hyoscine Butylbromide - Capsule (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA |
-2.48; -2.45; -2.36; -2.31 | 0.809 |
| SECONDARY Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS) |
-0.4; -0.2; -1.0; -0.8 | 0.079 |
| SECONDARY Global Assessment of Efficacy by Patient on 4-point Scale |
35; 35; 69; 76; 37; 30 | — |
| SECONDARY Number of Patients With Adverse Events |
10; 10; 5; 5; 0; 0 | — |
| SECONDARY Global Assessment of Tolerability by Investigator on a 4-point Scale |
51; 47; 72; 72; 21; 22 | — |
| SECONDARY Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination |
4; 2; 2; 1; 1; 1 | — |
| SECONDARY Percentage of Event for Time to Therapeutic Effect |
93.6; 92.1 | 0.531 |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02242305). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.