NCT02508142

Brief Summary

This study aims to assess the analgesic efficacy and safety of intravenous 20 mg Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with acute gastroenteritis in the emergency department.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

July 23, 2015

Last Update Submit

July 29, 2015

Conditions

Abdominal Cramps

Outcome Measures

Primary Outcomes (1)

  • Change in the mean pain intensity scores on visual analog scale

    Change in the mean pain intensity scores on visual analog scale

    15, 30, 60 minutes

Secondary Outcomes (2)

  • Adverse events

    6 hours

  • Incidence of rescue analgesia

    at 30 minute

Study Arms (2)

Hyoscine-N-Butylbromide

ACTIVE COMPARATOR

20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL)

Drug: Hyoscine-N-Butylbromide

Placebo

PLACEBO COMPARATOR

100 mL normal saline

Drug: Hyoscine-N-Butylbromide

Interventions

Hyoscine-N-ButylbromideDRUG

Study Drug: 20 mg/2 mL Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) ıntravenous form of Hyoscine-N-Butylbromide in normal saline is in the same appearance with placebo Study drug: 100 mL normal saline (placebo) (totally 100 mL) Drug: Fentanyl 1 mcg/kg as rescue analgesia at 30th minute

Also known as: Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş)
Hyoscine-N-ButylbromidePlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • Presenting to the emergency department with abdominal cramps associated with acute gastroenteritis
  • The pain intensity score upon screening is at least 20 mm on visual analog scale
  • Patients who agree to participate and sign the informed consent

You may not qualify if:

  • Patients younger than 18 years
  • Pain of \> 7 days
  • Use of any analgesic within 6 hours of ED presentation
  • Concomitant medication with spasmolytics, anticholinergics, drugs affecting gastrointestinal motility such as metoclopramide, loperamide, opioid analgesics
  • Patients who were administered dopamine antagonists before screening
  • Documented or self-reported hypersensitivity to hyoscine-n-butylbromide
  • Confirmed or suspected pregnancy
  • Breastfeeding
  • Glaucoma
  • Myasthenia gravis
  • Benign prostatic hyperplasia or urinary obstruction
  • Any suspected other cause of acute abdominal pain
  • Peritonism
  • Mechanical stenosis of the gastrointestinal tract, paralytic ileus, megacolon
  • Previous intestinal resection
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University, Faculty of Medicine, Emergency Departmentt

Kocaeli, 41380, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Colic

Interventions

Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Elif YAKA, M.D.

    Kocaeli University, Faculty of Medicine, Emergency Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif YAKA, M.D.

CONTACT

+90 262 3038551elifpostaciyaka@gmail.com

İbrahim U. Özturan, M.D.

CONTACT

+90 262 3038577ozturan.iu@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 24, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

TU(1)