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

Gastrointestinal Diseases Clinical Trial

Official title:

Buscopan® Plus, Buscopan®, Paracetamol and Placebo: Double-blind Randomized Group Comparison to Investigate the Efficacy and Tolerability of the Film-coated Tablets in Patients With Painful Gastric or Intestinal Spasms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229786
• Other study ID #: 218.202
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2014
• Last updated: August 28, 2014
• Start date: February 1998

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1637
• Est. primary completion date: October 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Drug:
• Buscopan® plus

• Buscopan®

• Paracetamol

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean decrease in pain intensity on a VAS (visual analog scale)		3 weeks	No
Secondary	Frequency of pain on a 4-stage verbal rating scale		up to 4 weeks	No
Secondary	Global assessment of efficacy by patient on a 5-point rating scale		up to 4 weeks	No
Secondary	Global assessment of efficacy by investigator on a 5-point rating scale		up to 4 weeks	No
Secondary	Number of patients with adverse events		up to 4 weeks	No

External Links

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