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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean decrease in pain intensity on a VAS (visual analog scale)