In short
Clinical trials investigating Hyoscine Butylbromide are studying how it is used in different medical settings, including imaging for cancer and support during labor. These trials look at accuracy, treatment planning, and delivery outcomes in specific patient groups such as people with prostate cancer, biliary tract cancer, and pregnant participants.
Key points
- Clinical trials investigating Hyoscine Butylbromide are all in Phase 3 and study different clinical settings. One trial looks at prostate cancer imaging and compares scan findings with tissue results. Another studies biliary tract cancer imaging and measures test accuracy with outcomes like sensitivity and specificity. A third trial studies pregnant participants with induction of labor and looks at whether delivery becomes spontaneous instead of operative. The target groups are people with high-risk prostate cancer, patients with potentially resectable biliary tract cancer, and pregnant female participants.
Trial overview
These studies investigate Hyoscine Butylbromide in different clinical settings, mainly alongside imaging tests or during labor care. All three trials are Phase 3 and are listed as authorised. The studies are interventional, which means researchers are giving a study treatment or procedure and then measuring the results.
Prostate cancer imaging study
The first study is titled “Evaluation of PSMA-PET and mpMRI in high-risk prostate cancer – using histopathologic validation.” It studies people with prostate cancer, especially high-risk disease, and includes 20 participants. The trial compares PSMA-PET and mpMRI, which are imaging tests, against histopathology, meaning tissue examination under a microscope. The goal is to see how well the scans find and outline the most important cancer areas inside the prostate.
This study includes several interventions used around the imaging process, including 18F-PSMA-1007, Buscopan 20 mg/ml injektionsvätska, lösning, Dotarem 279,3 mg/ml injektionsvätska lösning, and Glucagon Novo Nordisk 1 mg pulver och vätska till injektionsvätska, lösning. The primary endpoint is the detection of spatially defined aggressive prostate cancer lesions, or parts of lesions, compared with histopathology.
Biliary tract cancer imaging study
The second study is titled “The effect of [18F]F-FAPI PET-CT on management in patients with potentially resectable biliary tract cancers: prospective multicenter study and cost-effectivity analysis.” It includes patients with cholangiocarcinoma, which is a cancer of the bile ducts, and the summary also mentions intrahepatic, perihilar, and gall bladder cholangiocarcinoma. The study has 81 participants and is also Phase 3.
This trial looks at how [18F]F-FAPI PET-CT may help guide care in people with potentially resectable biliary tract cancer, meaning cancer that may still be removed by surgery. The primary outcomes are sensitivity, specificity, positive predictive value, and negative predictive value, which are ways to judge how accurate the test is. The listed interventions include [18F]-AlF-FAPI-74, GlucaGen®, HypoKit, and Scopolamine butylbromide Kalceks 20 mg/ml oplossing voor injectie.
Childbirth study
The third study is titled “A double-blind randomized placebo-controlled four-arm trial to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide to facilitate spontaneous (non-operative) delivery in pregnant female participants with induction of labor.” It studies childbirth in pregnant female participants who are having labor induced, and it plans to enroll 3000 people. The trial is double-blind, randomized, placebo-controlled, and has four arms, which means participants are assigned by chance to one of four groups and not everyone knows which treatment they receive.
The main goal is to see whether oral bicarbonate and intravenous butylscopolamine bromide can help more participants have a spontaneous delivery instead of an operative delivery. Operative delivery is defined in the trial as cesarean delivery, vacuum, or forceps. The listed interventions include placebo tablets, Buscopan Ampoules 20mg/ml solution for injection, sodium chloride infusion, and sodium bicarbonate capsules.
Outcomes and endpoints
Each trial measures a different main outcome, depending on the question being studied. In the prostate cancer study, the endpoint is whether imaging can identify aggressive lesions and match tissue findings. In the biliary tract cancer study, the endpoints focus on test accuracy, including sensitivity and specificity. In the childbirth study, the endpoint is spontaneous delivery versus operative delivery.
These endpoints show that the trials are not all studying the same outcome. Some are focused on diagnosis and imaging accuracy, while another is focused on labor outcomes.
Who can participate
The target populations are clearly different across the studies. One study is for people with high-risk prostate cancer, another is for patients with potentially resectable biliary tract cancer, and the third is for pregnant female participants with induction of labor. The trial records provided here do not list the full eligibility rules, so participation details beyond these groups are not available.
Key points for patients
- Hyoscine Butylbromide appears in trials as part of study procedures or treatment plans, not as a stand-alone topic.
- The research covers two cancer imaging studies and one labor study, so the settings are very different.
- All studies are Phase 3, which means they are advanced clinical trials with a larger patient focus.
- The main measurements are scan accuracy, tissue comparison, and delivery type.