Trial Outcomes & Findings for Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole (NCT NCT01281501)

NCT ID: NCT01281501

Last Updated: 2013-09-18

Results Overview

Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had \<50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores \> 40 millimeters were defined as "Non-responders"(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as "Responders" (good outcome).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 87 participants
• Primary outcome timeframe: 1 hour after treatment
• Results posted on: 2013-09-18

Participant Flow

Enrollment began in January, 1 2011 and finished at the end October, 31 2011 in the Emergency Department of King Chulalongkorn Memorial Hospital

We analyzed the data for all enrolled patients with the intention-to-treat principles.

Participant milestones

Measure	Conventional Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline	Pantoprazole Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Overall Study STARTED	44	43
Overall Study COMPLETED	44	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

Baseline characteristics by cohort

Measure	Conventional n=44 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline	Pantoprazole n=43 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	40 Participants n=7 Participants	83 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	29.8 years STANDARD_DEVIATION 8.1 • n=5 Participants	29.4 years STANDARD_DEVIATION 9.2 • n=7 Participants	29.6 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Thailand	44 participants n=5 Participants	43 participants n=7 Participants	87 participants n=5 Participants
Pretreatment 100-millimeter visual analog scale (VAS) scores	64 millimeters STANDARD_DEVIATION 13 • n=5 Participants	64 millimeters STANDARD_DEVIATION 16 • n=7 Participants	64 millimeters STANDARD_DEVIATION 14 • n=5 Participants

PRIMARY outcome

Timeframe: 1 hour after treatment

Population: All enrolled patients were analyzed with the intention-to-treat principles.

Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had <50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores > 40 millimeters were defined as "Non-responders"(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as "Responders" (good outcome).

Outcome measures

Measure	Conventional n=44 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline	Pantoprazole n=43 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment	17 millimeter Standard Deviation 24	19 millimeter Standard Deviation 23

SECONDARY outcome

Timeframe: pretreatment and 1 hour after treatment

"Responders" define the participants who have ≥ 50% decrease in post-treatment pain scores compared with the pre-treatment evaluation and also have the post-treatment scores ≤ 40 at the end of the study.

Outcome measures

Measure	Conventional n=44 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline	Pantoprazole n=43 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Number of Participants in the Predefined "Responders"	36 participants	32 participants

SECONDARY outcome

Timeframe: pretreatment and 1 hour after treatment

"Non-responders" defined the participants who had < 50% decrease in post-treatment VAS compared with pre-treatment evaluation or post-treatment scores > 40 at the end of the study.

Outcome measures

Measure	Conventional n=44 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline	Pantoprazole n=43 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Number of Participants in the Predefined "Non-responders"	8 participants	11 participants

SECONDARY outcome

Timeframe: 1 hour after treatment

The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour after treatment

The satisfaction will be assessed by a simple, self-reported yes/no question.

Outcome measures

Measure	Conventional n=44 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline	Pantoprazole n=43 Participants Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Number of Participants That Have Overall Satisfaction on the Treatment	34 participants	34 participants

Adverse Events

Conventional

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Pantoprazole

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Conventional n=44 participants at risk Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline	Pantoprazole n=43 participants at risk Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Eye disorders transient blurred vision	50.0% 22/44 • Number of events 22 • 1 hour	67.4% 29/43 • Number of events 29 • 1 hour
Gastrointestinal disorders dry mouth	27.3% 12/44 • Number of events 12 • 1 hour	14.0% 6/43 • Number of events 6 • 1 hour
Nervous system disorders dizziness	6.8% 3/44 • Number of events 3 • 1 hour	7.0% 3/43 • Number of events 3 • 1 hour
Cardiac disorders palpitation	4.5% 2/44 • Number of events 2 • 1 hour	0.00% 0/43 • 1 hour
Gastrointestinal disorders nausea	4.5% 2/44 • Number of events 2 • 1 hour	0.00% 0/43 • 1 hour
Nervous system disorders headache	4.5% 2/44 • Number of events 2 • 1 hour	0.00% 0/43 • 1 hour

Additional Information

Khrongwong Musikatavorn, MD

Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital.

Phone: +662-256-4000

Email: kmusikatavorn@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place