Comparison of Pantoprazole and Ranitidine in Dyspepsia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Akdeniz University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Akdeniz University Identifier:
First received: November 24, 2012
Last updated: November 29, 2012
Last verified: November 2012

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.

Condition Intervention Phase
Drug: Pantoprazole
Drug: Ranitidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial.

Resource links provided by NLM:

Further study details as provided by Akdeniz University:

Primary Outcome Measures:
  • Visual 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.

Secondary Outcome Measures:
  • Need 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.

Estimated Enrollment: 70
Study Start Date: October 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pantoprazole
Intravenous pantoprazole 40 mg flacon
Drug: Pantoprazole
Other Name: Pantpas
Active Comparator: ranitidine
Intravenous ranitidine 50 mg
Drug: Ranitidine
Other Name: Ulcuran

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01737840

Contact: Cenker Eken, Proffesor 00905056251217

Akdeniz University Recruiting
Antalya, Turkey, 07050
Contact: Cenker Eken, Proffesor    00905056251217   
Sub-Investigator: Engin Senay, Resident         
Sponsors and Collaborators
Akdeniz University
Study Director: Cenker Eken, Proffesor Akdeniz University
  More Information

Additional Information:
Responsible Party: Akdeniz University Identifier: NCT01737840     History of Changes
Other Study ID Numbers: 160
Study First Received: November 24, 2012
Last Updated: November 29, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Akdeniz University:
emergency department

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Ranitidine bismuth citrate
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H2 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Proton Pump Inhibitors
Therapeutic Uses processed this record on July 01, 2015