Status:
COMPLETED
Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Gastrointestinal Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1637 Patients enrolled
Trial Details
Trial ID
NCT02229786
Start Date
February 1 1998
Last Update
September 1 2014
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