Gastrointestinal Diseases
Conditions
Brief summary
Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.
Interventions
DRUGBuscopan® plus
DRUGBuscopan®
DRUGParacetamol
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean decrease in pain intensity on a VAS (visual analog scale) | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of pain on a 4-stage verbal rating scale | up to 4 weeks |
| Global assessment of efficacy by patient on a 5-point rating scale | up to 4 weeks |
| Global assessment of efficacy by investigator on a 5-point rating scale | up to 4 weeks |
| Number of patients with adverse events | up to 4 weeks |
Outcome results
None listed