Comparison of Pantoprazole and Ranitidine in Dyspepsia

Dyspepsia Clinical Trial

Official title:

Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737840
• Other study ID #: 160
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2012
• Last updated: June 27, 2015
• Start date: October 2012
• Est. completion date: January 2013

Study information

• Verified date: June 2015
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Pantoprazole
33 patients
• Ranitidine
33 patients

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Welling LR, Watson WA. The emergency department treatment of dyspepsia with antacids and oral lidocaine. Ann Emerg Med. 1990 Jul;19(7):785-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30th and 60th minutes	No
Secondary	Need for Additional Drug	The investigators are measuring the need for additional drug at the end of 60 minutes.	60 th minute	No

External Links

•   The web adress of the organization which this study is conducted.