Trial Outcomes & Findings for Comparison of Pantoprazole and Ranitidine in Dyspepsia (NCT NCT01737840)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66 participants

Primary outcome timeframe

30th and 60th minutes

Results posted on

2015-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Pantoprazole Intravenous pantoprazole 40 mg flacon Pantoprazole: 33 patients	Ranitidine Intravenous ranitidine 50 mg Ranitidine: 33 patients
Overall Study STARTED	35	35
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pantoprazole Intravenous pantoprazole 40 mg flacon Pantoprazole: 33 patients	Ranitidine Intravenous ranitidine 50 mg Ranitidine: 33 patients
Overall Study Diagnosed with an other pathology	2	2

Baseline Characteristics

Comparison of Pantoprazole and Ranitidine in Dyspepsia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pantoprazole n=33 Participants Intravenous pantoprazole 40 mg flacon Pantoprazole: 33 patients	Ranitidine n=33 Participants Intravenous ranitidine 50 mg Ranitidine: 33 patients	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.4 years STANDARD_DEVIATION 16.4 • n=5 Participants	34.8 years STANDARD_DEVIATION 13.9 • n=7 Participants	36.6 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Turkey	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pantoprazole n=33 Participants Intravenous pantoprazole 40 mg	Ranitidine n=33 Participants Intravenous ranitidine 50 mg
Visual Analogue Scale Score VAS score changes at 60 minutes	39.6 Visual Analogue Scale Standard Deviation 39	42.3 Visual Analogue Scale Standard Deviation 25
Visual Analogue Scale Score VAS scores changes at 30 minutes	27.6 Visual Analogue Scale Standard Deviation 28	28.3 Visual Analogue Scale Standard Deviation 23

SECONDARY outcome

Timeframe: 60 th minute

The investigators are measuring the need for additional drug at the end of 60 minutes.

Outcome measures

Outcome measures
Measure	Pantoprazole n=33 Participants Intravenous pantoprazole 40 mg	Ranitidine n=33 Participants Intravenous ranitidine 50 mg
Need for Additional Drug	13 participants	8 participants

Adverse Events

Pantoprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ranitidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cenker Eken

Akdeniz University

Phone: 00905321593948

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place