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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Acetaminophen; Butylscopolammonium Bromide; Scopolamine; Scopolamine Hydrobromide

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