A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain

July 18, 2014 updated by: hayri elicabuk, Pamukkale University

A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain: A Double-Blind, Randomized, Controlled Trial

  • 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • this is the placebo randomized double blinded clinical trial to compare the efficacy of these three drugs in this clinical setting.
  • A randomized clinical trial was conducted in the ED of Pamukkale University Medical Faculty Hospital
  • Study personnel (emergency physicians and nurses) were trained before the study.
  • When intravenous drugs (esomeprazol, ranitidine or plasebo) was being recommended, an eligibility checklist was completed by the attending physician.
  • If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial dispeptic pain severity ratings with VAS were recorded.
  • The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
  • All patients eligible for the study were randomized to one of three groups:
  • First Group: 40 mg Esomeprozol with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hidrotalcid
  • Second Group: 50mg Ranitidin with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hidrotalcid
  • Third Group: 150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hidrotalcid
  • Drug packs prepared in 5 ml syringes were numbered by an independent nurse, who not involved in the study.
  • Drug packs were prepared according to the computer-generated random number sequence to assign treatment allocations
  • The allocation list was kept by the emergency nurse. Patients received the esomeprazol, the ranitidin or the placebo medication schemes according to their random allocations.
  • After enrollment and recording of baseline information, the next numbered study drug pack was obtained, and administered as a infusion over 15 minutes.
  • Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
  • One researcher blinded to patient allocation observed the whole procedure and recorded the dyspeptic pain scores.
  • Patients in both groups received three types of medication in a similar manner (for example, 150 ml normal saline given as a slow intravenous infusion over 15 minutes), thus ensuring double blinding.
  • Dyspeptic pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10
  • Rescue medication [hidrotalcid 10ml (Talcid, Bayer, Istanbul, Turkey)] was given intravenously to patients if dyspeptic pain VAS scores ≥ 5 in thirty minutes after study drug administration.
  • All other medications required during the study also were recorded.
  • During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
286

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20000
        • Pamukkale Universty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients were eligible for inclusion if they were aged 18 years or older, 60 years or older,
  • had dyspspsia [VAS (visual analog scale) score >5] during their ED episode of care for which the attending physician recommended medication.

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Esomeprazole
40 mg Esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Drug: esomeprazole
40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Other Names:
  • Nexium, Astra Zeneca drugs, Södertalje
  • Esmara
  • Esom
Drug: hydrotalcid
150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Other Names:
  • Talcid, Bayer, Istanbul
EXPERIMENTAL: Ranitidine
50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Drug: esomeprazole
40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Other Names:
  • Nexium, Astra Zeneca drugs, Södertalje
  • Esmara
  • Esom
Drug: Ranitidine
50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Other Names:
  • Ulcuran, Abfar drugs, Istanbul
  • Ranitab
  • Ultidin
EXPERIMENTAL: placebo
150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Drug: hydrotalcid
150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Other Names:
  • Talcid, Bayer, Istanbul
Drug: Ranitidine
50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Other Names:
  • Ulcuran, Abfar drugs, Istanbul
  • Ranitab
  • Ultidin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
compare the effects of intravenous esomeprazol and ranitidin for the treatment of dyspepsia in the emergency setting.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: hayri elicabuk, md, Pamukkale Universty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDhayri84
  • 120841 (OTHER: Drug and Medical Device Institution)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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