Comparison of Pantoprazole and Ranitidine in Dyspepsia

Overview[ - collapse ][ - ]

Purpose The H0 hypothesis of the study there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency deparment. The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.
ConditionDyspepsia
InterventionDrug: Pantoprazole
Drug: Ranitidine
PhasePhase 4
SponsorAkdeniz University
Responsible PartyAkdeniz University
ClinicalTrials.gov IdentifierNCT01737840
First ReceivedNovember 24, 2012
Last UpdatedNovember 29, 2012
Last verifiedNovember 2012

Tracking Information[ + expand ][ + ]

First Received DateNovember 24, 2012
Last Updated DateNovember 29, 2012
Start DateOctober 2012
Estimated Primary Completion DateJanuary 2013
Current Primary Outcome MeasuresVisual analogue scale score [Time Frame: 30th and 60th minutes] [Designated as safety issue: No]The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale.
Current Secondary Outcome MeasuresNeed for additional drug [Time Frame: 60 th minute] [Designated as safety issue: No]The investigators are measuring the need for additional drug at the end of 60 minutes.

Descriptive Information[ + expand ][ + ]

Brief TitleComparison of Pantoprazole and Ranitidine in Dyspepsia
Official TitleIntravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial.
Brief Summary
The H0 hypothesis of the study there is no difference between pantoprazole and ranitidine in
treating patients presented with dyspepsia to the emergency deparment.

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. Protone 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 TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionDyspepsia
InterventionDrug: Pantoprazole
Other Names:
PantpasDrug: Ranitidine
Other Names:
Ulcuran
Study Arm (s)
  • Experimental: pantoprazole
    Intravenous pantoprazole 40 mg flacon
  • Active Comparator: ranitidine
    Intravenous ranitidine 50 mg

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment70
Estimated Completion DateJanuary 2013
Estimated Primary Completion DateJanuary 2013
Eligibility Criteria
Inclusion Criteria:

- Epigastric pain

- Older than 18 years old

Exclusion Criteria:

- 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Cenker Eken, Proffesor
00905056251217
cenkereken@akdeniz.edu.tr
Location CountriesTurkey

Administrative Information[ + expand ][ + ]

NCT Number NCT01737840
Other Study ID Numbers160
Has Data Monitoring CommitteeNo
Information Provided ByAkdeniz University
Study SponsorAkdeniz University
CollaboratorsNot Provided
Investigators Study Director: Cenker Eken, Proffesor Akdeniz University
Verification DateNovember 2012

Locations[ + expand ][ + ]

Akdeniz University
Antalya, Turkey, 07050
Contact: Cenker Eken, Proffesor | 00905056251217 | cenkereken@akdeniz.edu.tr
Sub-Investigator: Engin Senay, Resident
Recruiting