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

• 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