Comparison of Pantoprazole and Ranitidine in Dyspepsia

• ClinicalTrials.gov Identifier: NCT01737840
• Recruitment Status: Completed
• First Posted: November 30, 2012
• Results First Posted: July 23, 2015
• Last Update Posted: July 23, 2015
• Sponsor: Akdeniz University
• Information provided by (Responsible Party): Akdeniz University

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.

Condition or disease	Intervention/treatment	Phase
Dyspepsia	Drug: Pantoprazole; Drug: Ranitidine	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• 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.
• Study Start Date: October 2012
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Locations

Turkey

Akdeniz University

Antalya, Turkey, 07050

Sponsors and Collaborators

Akdeniz University

Investigators

• Study Director: Cenker Eken, Proffesor; Akdeniz University

More Information

Additional Information:

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

Publications:

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

• Responsible Party: Akdeniz University
• ClinicalTrials.gov Identifier: NCT01737840
• Other Study ID Numbers: 160
• First Posted: November 30, 2012
• 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; 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