Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms

Inclusion Criteria: * Male and female patients * Age: 18 - 70 years * Diagnosis: recurring painful gastric or intestinal spasms such as occur e.g. in irritable bowel syndrome, which are not organic in origin, have been present for at least 2 months, and are serious enough to interfere with everyday activities * Patient briefing as per §§ 40/41 of the Arzneimittelgesetz (AMG) and patient's declaration of Informed Consent in writing, in agreement with Good Clinical Practice (GCP) and current legal requirements * A pain assessment of 3 cm or more on the visual analog scale on at least one of the 2 days immediately preceding the second visit Exclusion Criteria: * Painful gastric or intestinal spasms of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance * Tumour pain/malignant growths * Patients with other severe pain states of organic origin (e.g. biliary colic) * Mechanical stenoses of the gastrointestinal tract, megacolon * Urinary retention associated with mechanical stenoses of the urinary tract (e.g. in prostate adenoma) * Narrow-angle glaucoma * Tachyarrhythmia * Myasthenia gravis * Glucose 6-phosphate dehydrogenase deficiency (danger of haemolytic anaemia) * Known hypersensitivity to N-butylscopolammonium bromide or paracetamol * Severe liver impairment (e.g. through chronic alcohol abuse, hepatitis): * a) Serum-Glutamate-Oxalacetat-Transaminase/ Aspartate Aminotransferase (SGOT) higher than four times the norm * b) Bilirubin \> 3 mg/dl * c) Quick's value \< 70% * Meulengracht-Gilbert syndrome (metabolic disturbance with episodes of jaundice) * Severe kidney failure: creatinine \> 2 mg/dl * Known depression or known mental illness, anxiety disturbance * Concomitant intake of analgesics, nonsteroidal antiinflammatory drugs (NSAIDs) and/or spasmolytics, anticholinergics, nitrates * Concomitant medication affecting gastrointestinal motility * Regular (daily) use of laxatives * Drugs that induce liver enzymes * Concomitant administration of chloramphenicol * Use of narcotics * Antidepressant treatment or treatment with psychoactive drugs * Pregnancy and lactation * Alcohol abuse (more than 60 g alcohol/day) * Frequent vomiting that might prevent adequate absorption of the active ingredient after the film-coated tablet is taken * Patients who are unlikely to be able to keep the examination appointments or cannot reliably take the study medication regularly * Simultaneous participation in another clinical study * Patients who are not trained in the VAS (PI) at Visit 1