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Comparison of Pantoprazole and Ranitidine in Dyspepsia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01737840
First Posted: November 30, 2012
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Akdeniz University
  Purpose

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.


Condition Intervention Phase
Dyspepsia Drug: Pantoprazole Drug: Ranitidine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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.


Secondary Outcome Measures:
  • Need for Additional Drug [ Time Frame: 60 th minute ]
    The investigators are measuring the need for additional drug at the end of 60 minutes.


Enrollment: 66
Study Start Date: October 2012
Study Completion Date: January 2013
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
33 patients
Other Name: Pantpas
Active Comparator: ranitidine
Intravenous ranitidine 50 mg
Drug: Ranitidine
33 patients
Other Name: Ulcuran

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01737840


Locations
Turkey
Akdeniz University
Antalya, Turkey, 07050
Sponsors and Collaborators
Akdeniz University
Investigators
Study Director: Cenker Eken, Proffesor Akdeniz University
  More Information

Additional Information:
Publications:
Responsible Party: Akdeniz University
ClinicalTrials.gov Identifier: NCT01737840     History of Changes
Other Study ID Numbers: 160
First Submitted: November 24, 2012
First Posted: November 30, 2012
Results First Submitted: March 16, 2015
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015
Last Verified: June 2015

Keywords provided by Akdeniz University:
dyspepsia
pantoprazole
ranitidine
emergency department

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Pantoprazole
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs