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

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

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Drug: Placebo; Drug: Paracetamol; Drug: Buscopan® plus; Drug: Buscopan®

• Study Type: Interventional
• Enrollment (Actual): 1637
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Active Comparator: Paracetamol	Drug: Paracetamol
Experimental: Buscopan® plus	Drug: Buscopan® plus
Active Comparator: Buscopan®	Drug: Buscopan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean decrease in pain intensity on a VAS (visual analog scale)	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 1998
• Primary Completion (Actual): October 1, 1999

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: August 28, 2014
• First Posted (Estimate): September 1, 2014

Study Record Updates

• Last Update Posted (Estimate): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Mydriatics; Acetaminophen; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: 218.202