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

NCT02229786 | Completed Phase 2

• 1 other identifier: 218.202
• Study Type: interventional
• Target: 1,637
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Mean decrease in pain intensity on a VAS (visual analog scale)

  3 weeks

Secondary Outcomes (4)

• 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

Study Arms (4)

Buscopan® plus

EXPERIMENTAL

Drug: Buscopan® plus

Buscopan®

ACTIVE COMPARATOR

Drug: Buscopan®

Paracetamol

ACTIVE COMPARATOR

Drug: Paracetamol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Buscopan® plus DRUG

Buscopan® plus

Buscopan® DRUG

Buscopan®

Paracetamol DRUG

Paracetamol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Butylscopolammonium Bromide; Acetaminophen

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Acetanilides; Anilides; Amides; Aniline Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: February 1, 1998
• Primary Completion: October 1, 1999
• Last Updated: September 1, 2014

Record last verified: 2014-08