Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms
- Conditions
- Gastrointestinal Diseases
- Interventions
- Registration Number
- NCT02229786
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1637
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Buscopan® Buscopan® - Paracetamol Paracetamol - Buscopan® plus Buscopan® plus -
- Primary Outcome Measures
Name Time Method Mean decrease in pain intensity on a VAS (visual analog scale) 3 weeks
- Secondary Outcome Measures
Name Time Method 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