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Hyoscine Butylbromide

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.

Table of Contents

Trial overview

These studies investigate Hyoscine Butylbromide in different clinical settings, mainly alongside imaging tests or during labor care.[1][2][3] All three trials are Phase 3 and are listed as authorised.[1][2][3] The studies are interventional, which means researchers are giving a study treatment or procedure and then measuring the results.[1][2][3]

Prostate cancer imaging study

The first study is titled “Evaluation of PSMA-PET and mpMRI in high-risk prostate cancer – using histopathologic validation.”[1] It studies people with prostate cancer, especially high-risk disease, and includes 20 participants.[1] The trial compares PSMA-PET and mpMRI, which are imaging tests, against histopathology, meaning tissue examination under a microscope.[1] The goal is to see how well the scans find and outline the most important cancer areas inside the prostate.[1]

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.[1] The primary endpoint is the detection of spatially defined aggressive prostate cancer lesions, or parts of lesions, compared with histopathology.[1]

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.”[2] It includes patients with cholangiocarcinoma, which is a cancer of the bile ducts, and the summary also mentions intrahepatic, perihilar, and gall bladder cholangiocarcinoma.[2] The study has 81 participants and is also Phase 3.[2]

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.[2] The primary outcomes are sensitivity, specificity, positive predictive value, and negative predictive value, which are ways to judge how accurate the test is.[2] The listed interventions include [18F]-AlF-FAPI-74, GlucaGen®, HypoKit, and Scopolamine butylbromide Kalceks 20 mg/ml oplossing voor injectie.[2]

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.”[3] It studies childbirth in pregnant female participants who are having labor induced, and it plans to enroll 3000 people.[3] 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.[3]

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.[3] Operative delivery is defined in the trial as cesarean delivery, vacuum, or forceps.[3] The listed interventions include placebo tablets, Buscopan Ampoules 20mg/ml solution for injection, sodium chloride infusion, and sodium bicarbonate capsules.[3]

Outcomes and endpoints

Each trial measures a different main outcome, depending on the question being studied.[1][2][3] In the prostate cancer study, the endpoint is whether imaging can identify aggressive lesions and match tissue findings.[1] In the biliary tract cancer study, the endpoints focus on test accuracy, including sensitivity and specificity.[2] In the childbirth study, the endpoint is spontaneous delivery versus operative delivery.[3]

These endpoints show that the trials are not all studying the same outcome.[1][2][3] Some are focused on diagnosis and imaging accuracy, while another is focused on labor outcomes.[1][2][3]

Who can participate

The target populations are clearly different across the studies.[1][2][3] 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.[1][2][3] The trial records provided here do not list the full eligibility rules, so participation details beyond these groups are not available.[1][2][3]

Key points for patients

  • Hyoscine Butylbromide appears in trials as part of study procedures or treatment plans, not as a stand-alone topic.[1][2][3]
  • The research covers two cancer imaging studies and one labor study, so the settings are very different.[1][2][3]
  • All studies are Phase 3, which means they are advanced clinical trials with a larger patient focus.[1][2][3]
  • The main measurements are scan accuracy, tissue comparison, and delivery type.[1][2][3]
Trial ID Phase Condition studied Status Enrollment
2022-501892-14-00 Phase 3 Prostate cancer Authorised 20
2023-507938-24-00 Phase 3 Cholangiocarcinoma Authorised 81
NCT05719467 Phase 3 Childbirth Authorised 3000

FAQ

  • What are clinical trials of Hyoscine Butylbromide studying? These trials are studying how Hyoscine Butylbromide is used in imaging or procedure settings, not as a general treatment description. The main goals include measuring accuracy of scans, helping with cancer assessment, and supporting labor outcomes.
  • Who may take part in these trials? The target groups include people with high-risk prostate cancer, patients with potentially resectable biliary tract cancer, and pregnant female participants with induction of labor. Each trial has its own eligibility rules.
  • What trial phases are listed? All three trials are listed as Phase 3. This means they are advanced studies that test how well the approach works in larger groups of people.
  • What conditions are being studied? The trials focus on prostate cancer, cholangiocarcinoma, and childbirth. One study also includes gall bladder and intrahepatic or perihilar bile duct cancers within the broader biliary tract cancer group.
  • What outcomes are measured in these trials? The trials measure different endpoints depending on the study. These include scan accuracy compared with tissue findings, sensitivity and specificity, and the rate of spontaneous versus operative delivery.

Ongoing Clinical Trials on Hyoscine Butylbromide

  • Study on the Impact of [18F]-AlF-FAPI-74, Glucagon, and Hyoscine Butylbromide in Patients with Resectable Biliary Tract Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Use of 18F-PSMA-1007, Hyoscine Butylbromide, and Gadoteric Acid in Imaging for Patients with High-Risk Prostate Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on the Effectiveness of Oral Sodium Bicarbonate and Intravenous Hyoscine Butylbromide for Facilitating Natural Childbirth in Pregnant Women Induced for Labor

    Not recruiting

    1 1 1
    Investigated drugs:
    Norway

Glossary

  • Phase 3: An advanced stage of clinical research that studies how well a treatment or test works in larger groups of people.
  • Interventional study: A study where researchers give a treatment, test, or procedure and then measure the results.
  • Prostate cancer: A cancer that starts in the prostate, a gland in men.
  • Cholangiocarcinoma: A cancer that starts in the bile ducts, which are tubes that carry bile from the liver.
  • Biliary tract cancer: Cancer that begins in the bile ducts or gallbladder.
  • Histopathology: Study of tissue under a microscope to see if disease is present and how aggressive it is.
  • Sensitivity: How well a test finds people who truly have the disease.
  • Specificity: How well a test correctly identifies people who do not have the disease.
  • Positive predictive value: The chance that a positive test result is truly correct.
  • Negative predictive value: The chance that a negative test result is truly correct.
  • Operative delivery: A birth that needs medical help, such as cesarean delivery, vacuum, or forceps.

References