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

Launched by BOEHRINGER INGELHEIM · Aug 28, 2014

Keywords

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Gender

ALL

Eligibility criteria

• 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