Back to resultsComparison of Pantoprazole and Ranitidine in Dyspepsia
Primary Purpose
Dyspepsia
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Pantoprazole
Ranitidine
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia focused on measuring dyspepsia, pantoprazole, ranitidine, emergency department
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
Sites / Locations
- Akdeniz University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pantoprazole
ranitidine
Arm Description
Intravenous pantoprazole 40 mg flacon
Intravenous ranitidine 50 mg
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Need for Additional Drug
The investigators are measuring the need for additional drug at the end of 60 minutes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01737840
Brief Title
Comparison of Pantoprazole and Ranitidine in Dyspepsia
Official Title
Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akdeniz University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
dyspepsia, pantoprazole, ranitidine, emergency department
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pantoprazole
Arm Type
Experimental
Arm Description
Intravenous pantoprazole 40 mg flacon
Arm Title
ranitidine
Arm Type
Active Comparator
Arm Description
Intravenous ranitidine 50 mg
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
Pantpas
Intervention Description
33 patients
Intervention Type
Drug
Intervention Name(s)
Ranitidine
Other Intervention Name(s)
Ulcuran
Intervention Description
33 patients
Primary Outcome Measure Information:
Title
Visual Analogue Scale Score
Description
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.
Time Frame
30th and 60th minutes
Secondary Outcome Measure Information:
Title
Need for Additional Drug
Description
The investigators are measuring the need for additional drug at the end of 60 minutes.
Time Frame
60 th minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cenker Eken, Proffesor
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
ZIP/Postal Code
07050
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
2202240
Citation
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.
Results Reference
background
Links:
URL
http://www.akdeniz.edu.tr
Description
The web adress of the organization which this study is conducted.
Learn more about this trial
Comparison of Pantoprazole and Ranitidine in Dyspepsia
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