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

NCT ID: NCT02229786

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1637 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-02-28

Brief Summary

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

Conditions

Gastrointestinal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Buscopan® plus

Group Type: EXPERIMENTAL

Buscopan® plus

Intervention Type: DRUG

Buscopan®

Group Type: ACTIVE_COMPARATOR

Buscopan®

Intervention Type: DRUG

Paracetamol

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Buscopan® plus

Intervention Type: DRUG

Buscopan®

Intervention Type: DRUG

Paracetamol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

218.202

Identifier Type: -

Identifier Source: org_study_id