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

NCT ID: NCT02197143

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-07-31

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.

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.

Conditions

Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Esomeprazole

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

Group Type: EXPERIMENTAL

esomeprazole

Intervention Type: DRUG

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

hydrotalcid

Intervention Type: DRUG

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

Ranitidine

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

Group Type: EXPERIMENTAL

esomeprazole

Intervention Type: DRUG

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

Ranitidine

Intervention Type: DRUG

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

placebo

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

Group Type: EXPERIMENTAL

Ranitidine

Intervention Type: DRUG

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

hydrotalcid

Intervention Type: DRUG

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

Interventions

esomeprazole

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

Intervention Type: DRUG

Ranitidine

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

Intervention Type: DRUG

hydrotalcid

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

Intervention Type: DRUG

Other Intervention Names

Nexium, Astra Zeneca drugs, Södertalje; Esmara; Esom; Ulcuran, Abfar drugs, Istanbul; Ranitab; Ultidin; Talcid, Bayer, Istanbul

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

hayri elicabuk

md

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hayri elicabuk, md

Role: PRINCIPAL_INVESTIGATOR

pamukkale universty

Locations

Pamukkale Universty

Denizli, Denizli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

120841

Identifier Type: OTHER

Identifier Source: secondary_id

MDhayri84

Identifier Type: -

Identifier Source: org_study_id