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

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ClinicalTrials.gov Identifier: NCT02229786
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Drug: Buscopan® plus Drug: Buscopan® Drug: Paracetamol Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1637 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : February 1998
Actual Primary Completion Date : October 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arm Intervention/treatment
Experimental: Buscopan® plus Drug: Buscopan® plus
Active Comparator: Buscopan® Drug: Buscopan®
Active Comparator: Paracetamol Drug: Paracetamol
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Mean decrease in pain intensity on a VAS (visual analog scale) [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Frequency of pain on a 4-stage verbal rating scale [ Time Frame: up to 4 weeks ]
  2. Global assessment of efficacy by patient on a 5-point rating scale [ Time Frame: up to 4 weeks ]
  3. Global assessment of efficacy by investigator on a 5-point rating scale [ Time Frame: up to 4 weeks ]
  4. Number of patients with adverse events [ Time Frame: up to 4 weeks ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02229786     History of Changes
Other Study ID Numbers: 218.202
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Acetaminophen
Scopolamine
Butylscopolammonium Bromide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Antiemetics
Gastrointestinal Agents
Mydriatics