NCT02197143

Brief Summary

  • Currently, Proton Pump Inhibitors and H2Receptor Blockers are widely used by emergency physicians in Turkey for the treatment of patients with dyspepsia.
  • The objective of the study was to assess whether intravenous esomeprazol has superior dyspeptic pain reduction compared with ranitidine or hydrotalcid in emergency department (ED) adults
  • The investigators second aim was to compare recurrent dyspeptic pain within 24 hours after discharge and cost of treatments in the treatment of dyspepsia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
286

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

July 9, 2014

Last Update Submit

July 18, 2014

Conditions

Dyspepsia

Keywords

esomeprazoleranitidinehydrotalcidtreatment of dyspepsiaemergancy medicine

Outcome Measures

Primary Outcomes (1)

  • compare the effects of intravenous esomeprazol and ranitidin for the treatment of dyspepsia in the emergency setting.

    This work took 17 months

    Patients in both groups received three types of medication than dyspeptic pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10.

Study Arms (3)

Esomeprazole

EXPERIMENTAL

40 mg Esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid

Drug: esomeprazoleDrug: hydrotalcid

Ranitidine

EXPERIMENTAL

50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid

Drug: esomeprazoleDrug: Ranitidine

placebo

EXPERIMENTAL

150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid

Drug: RanitidineDrug: hydrotalcid

Interventions

esomeprazoleDRUG

40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid

Also known as: Nexium, Astra Zeneca drugs, Södertalje, Esmara, Esom
EsomeprazoleRanitidine
RanitidineDRUG

50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid

Also known as: Ulcuran, Abfar drugs, Istanbul, Ranitab, Ultidin
Ranitidineplacebo
hydrotalcidDRUG

150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid

Also known as: Talcid, Bayer, Istanbul
Esomeprazoleplacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • had dyspspsia \[VAS (visual analog scale) score \>5\] during their ED episode of care for which the attending physician recommended medication.

You may not qualify if:

  • pretreatment 100-mm linear visual analog scale (VAS) pain score less than 50 mm;
  • known cases of malignancy or terminal illness;
  • known cases of major medical problems (eg, any evidence of active structural or functional abnormality of the hearts, chronic renal failure)
  • allergy or previous adverse reaction to study drugs studied
  • received agents to inhibit the secretion of acid (PPIs or histamine-2 receptor antagonists), nonsteroidal anti-inflammatory drugs,
  • who consumed alcohol within 4 hours before the ED visit
  • diarrhea more than 2 times within the past 24 hours;
  • being suspected to have other ED diagnoses (eg, gut obstruction, biliary colic, pancreatitis, hepatitis, or localized hepatobiliary infections);
  • being pregnant or breast-feeding; and
  • inability to comprehend the VAS evaluation.
  • and patients who refused to participate study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale Universty

Denizli, Denizli, 20000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

EsomeprazoleRanitidinehydrotalcite

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFurans

Study Officials

  • hayri elicabuk, md

    pamukkale universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 22, 2014

Study Start

March 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

TU(1)