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. |
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Condition | Dyspepsia |
Intervention | Drug: Pantoprazole Drug: Ranitidine |
Phase | Phase 4 |
Sponsor | Akdeniz University |
Responsible Party | Akdeniz University |
ClinicalTrials.gov Identifier | NCT01737840 |
First Received | November 24, 2012 |
Last Updated | November 29, 2012 |
Last verified | November 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | November 24, 2012 |
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Last Updated Date | November 29, 2012 |
Start Date | October 2012 |
Estimated Primary Completion Date | January 2013 |
Current 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. |
Current 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. |
Descriptive Information[ + expand ][ + ]
Brief Title | Comparison of Pantoprazole and Ranitidine in Dyspepsia |
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Official Title | Intravenous 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 Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Dyspepsia |
Intervention | Drug: Pantoprazole Other Names: PantpasDrug: Ranitidine Other Names: Ulcuran |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 70 |
Estimated Completion Date | January 2013 |
Estimated Primary Completion Date | January 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Cenker Eken, Proffesor 00905056251217 cenkereken@akdeniz.edu.tr |
Location Countries | Turkey |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01737840 |
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Other Study ID Numbers | 160 |
Has Data Monitoring Committee | No |
Information Provided By | Akdeniz University |
Study Sponsor | Akdeniz University |
Collaborators | Not Provided |
Investigators | Study Director: Cenker Eken, Proffesor Akdeniz University |
Verification Date | November 2012 |
Locations[ + expand ][ + ]
Akdeniz University | Antalya, Turkey, 07050 Contact: Cenker Eken, Proffesor | 00905056251217 | cenkereken@akdeniz.edu.trSub-Investigator: Engin Senay, Resident Recruiting |
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