CompletedPhase 3

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

302 participantsStarted 2008-11-01

Plain-language 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

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
✕. 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
✕. 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

What they're measuring

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)

Trial details

NCT IDNCT02242305

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-07-20

Results submitted2017-03-29

View on ClinicalTrials.gov More Abdominal Pain trials