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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02197143
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
hayri elicabuk, Pamukkale University

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: esomeprazole Drug: Ranitidine Drug: hydrotalcid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain: A Double-Blind, Randomized, Controlled Trial
Study Start Date : March 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
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 Name: 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: 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

Drug: hydrotalcid
150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
Other Name: Talcid, Bayer, Istanbul




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197143


Locations
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Turkey
Pamukkale Universty
Denizli, Turkey, 20000
Sponsors and Collaborators
Pamukkale University
Investigators
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Principal Investigator: hayri elicabuk, md pamukkale universty

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Responsible Party: hayri elicabuk, md, Pamukkale University
ClinicalTrials.gov Identifier: NCT02197143    
Other Study ID Numbers: MDhayri84
120841 ( Other Identifier: Drug and Medical Device Institution )
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014
Keywords provided by hayri elicabuk, Pamukkale University:
esomeprazole
ranitidine
hydrotalcid
treatment of dyspepsia
emergancy medicine
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs