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

Primary Purpose

Gastrointestinal Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Buscopan® plus
Buscopan®
Paracetamol
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Diseases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Buscopan® plus

    Buscopan®

    Paracetamol

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Frequency of pain on a 4-stage verbal rating scale
    Global assessment of efficacy by patient on a 5-point rating scale
    Global assessment of efficacy by investigator on a 5-point rating scale
    Number of patients with adverse events

    Full Information

    First Posted
    August 28, 2014
    Last Updated
    August 28, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02229786
    Brief Title
    Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1998 (undefined)
    Primary Completion Date
    October 1999 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    1637 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Buscopan® plus
    Arm Type
    Experimental
    Arm Title
    Buscopan®
    Arm Type
    Active Comparator
    Arm Title
    Paracetamol
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Buscopan® plus
    Intervention Type
    Drug
    Intervention Name(s)
    Buscopan®
    Intervention Type
    Drug
    Intervention Name(s)
    Paracetamol
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Mean decrease in pain intensity on a VAS (visual analog scale)
    Time Frame
    3 weeks
    Secondary Outcome Measure Information:
    Title
    Frequency of pain on a 4-stage verbal rating scale
    Time Frame
    up to 4 weeks
    Title
    Global assessment of efficacy by patient on a 5-point rating scale
    Time Frame
    up to 4 weeks
    Title
    Global assessment of efficacy by investigator on a 5-point rating scale
    Time Frame
    up to 4 weeks
    Title
    Number of patients with adverse events
    Time Frame
    up to 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

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