NCT01737840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

July 23, 2015

Completed
Last Updated

July 23, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

November 24, 2012

Results QC Date

March 16, 2015

Last Update Submit

June 27, 2015

Conditions

Dyspepsia

Keywords

dyspepsiapantoprazoleranitidineemergency department

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Need for Additional Drug

    60 th minute

Study Arms (2)

pantoprazole

EXPERIMENTAL

Intravenous pantoprazole 40 mg flacon

Drug: Pantoprazole

ranitidine

ACTIVE COMPARATOR

Intravenous ranitidine 50 mg

Drug: Ranitidine

Interventions

PantoprazoleDRUG

33 patients

Also known as: Pantpas
pantoprazole
RanitidineDRUG

33 patients

Also known as: Ulcuran
ranitidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Epigastric pain
  • Older than 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07050, Turkey (Türkiye)

Location

Related 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. doi: 10.1016/s0196-0644(05)81704-4.

    PMID: 2202240BACKGROUND

Related Links

MeSH Terms

Conditions

DyspepsiaEmergencies

Interventions

PantoprazoleRanitidine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingFurans

Results Point of Contact

Title
Cenker Eken
Organization
Akdeniz University
cenkereken@akdeniz.edu.tr
00905321593948

Study Officials

  • Cenker Eken, Proffesor

    Akdeniz University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2012

First Posted

November 30, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 23, 2015

Results First Posted

July 23, 2015

Record last verified: 2015-06

Locations

TU(1)