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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Diseases

Treatments: Drug: Buscopan® plus; Drug: Buscopan®; Drug: Placebo; Drug: Paracetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02229786

218.202

Details and patient eligibility

About

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

Enrollment: 1,637 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,637 participants in 4 patient groups, including a placebo group

Buscopan® plus

Experimental group

Treatment:

Drug: Buscopan® plus

Buscopan®

Active Comparator group

Treatment:

Drug: Buscopan®

Paracetamol

Active Comparator group

Treatment:

Drug: Paracetamol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo