DyspepsiaPhase 4NCT01737840
Comparison of Pantoprazole and Ranitidine in Dyspepsia
A Phase 4 study testing Pantoprazole and Ranitidine in people with Dyspepsia, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department. The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Pantoprazole and Ranitidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2012to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Epigastric pain
- Older than 18 years old
Who cannot join
- Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of the emergency deparment evaluation period.
- Pregnancy
- Patients with unstable vital signs
- Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last one hour.
- Allergy to H2 receptor blockers and proton pomp inhibitors.
- Patients denied to give inform consent and who are illiterate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial.
The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.
The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.
Read the detailed description
Dyspepsia is one of the common complaints in emergency department. Proton pomp inhibitors, H2 receptor blockers and anti-acids are common drugs for treating dyspepsia in emergency department. However there is no study in the emergency department comparing the effectiveness of these drugs. So the investigators planned this study which drug is effective in these patients in order to provide a cost-effective treatment in dyspeptic patients.
- Conditions
- Dyspepsia
- Being tested
- Pantoprazole, Ranitidine
- Keywords
- dyspepsia, pantoprazole, ranitidine, emergency department
- Medical subject headings
- Dyspepsia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Also called Pantpas
33 patients
RanitidineDrug
Also called Ulcuran
33 patients
| Study group | Role | What they receive |
|---|---|---|
| pantoprazole | Experimental | Intravenous pantoprazole 40 mg flacon Receives: Drug: Pantoprazole |
| ranitidine | Active comparator | Intravenous ranitidine 50 mg Receives: Drug: Ranitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Score
The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain.
Measured: 30th and 60th minutes
Secondary outcomes (1)
Need for Additional Drug
The investigators are measuring the need for additional drug at the end of 60 minutes.
Measured: 60 th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cenker Eken, Proffesor, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737840
- Sponsor's protocol ID
- 160
- Status last verified
- Jun 2015
- First submitted
- 24 Nov 2012
- Last updated
- 23 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Welling LR, Watson WA. The emergency department treatment of dyspepsia with antacids and oral lidocaine. Ann Emerg Med. 1990 Jul;19(7):785-8. doi: 10.1016/s0196-0644(05)81704-4.
PubMed 2202240
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01737840
- Acronym / sponsor ID
- 160
- Conditions
- Dyspepsia
- Keywords
- dyspepsia, pantoprazole, ranitidine, emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Posted 23 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.
The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.
Detailed description
Dyspepsia is one of the common complaints in emergency department. Proton pomp inhibitors, H2 receptor blockers and anti-acids are common drugs for treating dyspepsia in emergency department. However there is no study in the emergency department comparing the effectiveness of these drugs. So the investigators planned this study which drug is effective in these patients in order to provide a cost-effective treatment in dyspeptic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pantoprazole | Experimental | Drug: PantoprazoleIntravenous pantoprazole 40 mg flacon |
| ranitidine | Active comparator | Drug: RanitidineIntravenous ranitidine 50 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Epigastric pain
- Older than 18 years old
Key exclusion criteria (6 listed)
- Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of the emergency deparment evaluation period.
- Pregnancy
- Patients with unstable vital signs
- Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last one hour.
- Allergy to H2 receptor blockers and proton pomp inhibitors.
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 |
|---|---|---|
| PantoprazoleAlso: Pantpas33 patients | Drug | pantoprazole |
| RanitidineAlso: Ulcuran33 patients | Drug | ranitidine |
Primary outcome
Visual Analogue Scale Score
Time frame: 30th and 60th minutes
The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain.
1 secondary outcome
Need for Additional Drug
Time frame: 60 th minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2202240Welling LR, Watson WA. The emergency department treatment of dyspepsia with antacids and oral lidocaine. Ann Emerg Med. 1990 Jul;19(7):785-8. doi: 10.1016/s0196-0644(05)81704-4.
- The web adress of the organization which this study is conducted.Link provided by the sponsor.
Related trials for Dyspepsia
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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.
Cenker Eken, Proffesor study director
Akdeniz University
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 Pantoprazole and Ranitidine in people with Dyspepsia, run by Akdeniz 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 6 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 23 Jul 2015. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analogue Scale Score (time frame: 30th and 60th minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737840, which also lists 1 linked publication.
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 23 Jul 2015.