Completed

Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial

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What is being tested

Hyoscine N Butylbromide

+ Placebo

DrugOther
Who is being recruted

Neurologic Manifestations+3

+ Pain

+ Signs and Symptoms

From 18 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: September 2021
See protocol details

Summary

Principal SponsorAnkara City Hospital Bilkent
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 8, 2021

Actual date on which the first participant was enrolled.

One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.

Official TitleManagement of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial
NCT04682860
Principal SponsorAnkara City Hospital Bilkent
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsAbdominal Pain

Criteria

1 inclusion criteria required to participate
Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain
7 exclusion criteria prevent from participating
Peritonitis
Hemodynamic instability
Pregnancy
Inability to give consent
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
In the treatment arm, the patient will be injected intravenously with 1ml 20 mg of Hyoscine butylbromide and 1 ml of normal saline intravenously within 30 seconds.

Group II

Placebo
In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ankara City Hospital

Ankara, Turkey (Türkiye)Open Ankara City Hospital in Google Maps
CompletedOne Study Center