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

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

Official Title
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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

Conditions
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Gastrointestinal Diseases

Intervention / Treatment
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* Drug: Buscopan® plus
* Drug: Buscopan®
* Drug: Paracetamol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buscopan® plus<br> | Drug: Buscopan® plus<br> <br> |
| Active Comparator: Buscopan®<br> | Drug: Buscopan®<br> <br> |
| Active Comparator: Paracetamol<br> | Drug: Paracetamol<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |