Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms (NCT02229786) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms
1,637 participantsStarted 1998-02
Plain-language summary
Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol, and placebo in patients with painful gastric or intestinal spasms.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Mean decrease in pain intensity on a VAS (visual analog scale)