DyspepsiaPhase 4NCT02197143
A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain
A Phase 4 study testing esomeprazole, Ranitidine and hydrotalcid in people with Dyspepsia, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- esomeprazole, Ranitidine and hydrotalcid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- esomeprazole, Ranitidine, hydrotalcid
- Keywords
- esomeprazole, ranitidine, hydrotalcid, treatment of dyspepsia, emergancy medicine
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
Also called Nexium, Astra Zeneca drugs, Södertalje, Esmara, Esom
40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
RanitidineDrug
Also called Ulcuran, Abfar drugs, Istanbul, Ranitab, Ultidin
50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
hydrotalcidDrug
Also called Talcid, Bayer, Istanbul
150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole | Experimental | 40 mg Esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid Receives: Drug: esomeprazole; Drug: hydrotalcid |
| Ranitidine | Experimental | 50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid Receives: Drug: esomeprazole; Drug: Ranitidine |
| placebo | Experimental | 150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid Receives: Drug: Ranitidine; Drug: hydrotalcid |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the effects of intravenous esomeprazol and ranitidin for the treatment of dyspepsia in the emergency setting.
This work took 17 months
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startMar 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hayri elicabuk, Pamukkale University
- Investigators
- hayri elicabuk, md, Principal investigator, pamukkale universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197143
- Sponsor's protocol ID
- MDhayri84
- Other IDs
- 120841
- Status last verified
- Jul 2014
- First submitted
- 9 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain: A Double-Blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02197143
- Acronym / sponsor ID
- MDhayri84
- Conditions
- Dyspepsia
- Keywords
- esomeprazole, ranitidine, hydrotalcid, treatment of dyspepsia, emergancy medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole | Experimental | Drug: esomeprazole, Drug: hydrotalcid40 mg Esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid |
| Ranitidine | Experimental | Drug: esomeprazole, Drug: Ranitidine50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid |
| placebo | Experimental | Drug: Ranitidine, Drug: hydrotalcid150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esomeprazoleAlso: Nexium, Astra Zeneca drugs, Södertalje, Esmara, Esom40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid | Drug | Esomeprazole, Ranitidine |
| RanitidineAlso: Ulcuran, Abfar drugs, Istanbul, Ranitab, Ultidin50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid | Drug | Ranitidine, placebo |
| hydrotalcidAlso: Talcid, Bayer, Istanbul150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid | Drug | Esomeprazole, placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
Related trials for Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hayri elicabuk, md principal investigator
pamukkale universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing esomeprazole, Ranitidine and hydrotalcid in people with Dyspepsia, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2014.