Comparison of Pantoprazole and Ranitidine in Dyspepsia

Phase 4

Completed

• Conditions: Dyspepsia
• Interventions: Drug: Ranitidine; Drug: Pantoprazole

• Registration Number: NCT01737840
• Lead Sponsor: Akdeniz University

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-24
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-11-30
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2015-03-16
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-27
• Last Update Submitted: 2015-06-27
• Results First Posted: 2015-07-23
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ranitidine	Ranitidine	Intravenous ranitidine 50 mg
pantoprazole	Pantoprazole	Intravenous pantoprazole 40 mg flacon

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale Score	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

Name	Time	Method
Need for Additional Drug	60 th minute	The investigators are measuring the need for additional drug at the end of 60 minutes.

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Turkey