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Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Khrongwong Musikatavorn, MD., Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01281501
First received: January 17, 2011
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
Results First Received: April 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Dyspepsia
Emergency
Pain
Interventions: Drug: Normal saline
Drug: Pantoprazole
Drug: Oral antacid
Drug: Hyoscine butylbromide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment began in January, 1 2011 and finished at the end October, 31 2011 in the Emergency Department of King Chulalongkorn Memorial Hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We analyzed the data for all enrolled patients with the intention-to-treat principles.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Conventional     Pantoprazole  
STARTED     44     43  
COMPLETED     44     43  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Conventional     Pantoprazole     Total  
Number of Participants  
[units: participants]
 		  44     43     87  
Age  
[units: participants]
 		     
<=18 years     1     3     4  
Between 18 and 65 years     43     40     83  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  29.8  ± 8.1     29.4  ± 9.2     29.6  ± 8.6  
Gender  
[units: participants]
 		     
Female     33     35     68  
Male     11     8     19  
Region of Enrollment  
[units: participants]
 		     
Thailand     44     43     87  
Pretreatment 100-millimeter visual analog scale (VAS) scores [1]
[units: millimeters]
Mean ± Standard Deviation 		  64  ± 13     64  ± 16     64  ± 14  
[1] Self-marked pain scores on the 100-millimeter VAS lines were assessed by the patients before treatment. The minimal and maximal scores were between 0-100 millimeters. Good responders (good outcome) defined those had ≥ 50% decreases in post-treatment VAS compared with the pre-treatment evaluation and post-treatment scores ≤ 40 millimeters at the end of the study. Non-responders (worse outcome) defined those who had <50% decreases in post-treatment VAS compared with the pre-treatment evaluation or post-treatment scores > 40 millimeters at the end of the study.



  Outcome Measures
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1.  Primary:   Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment   [ Time Frame: 1 hour after treatment ]
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Measure Type Primary
Measure Title Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
Measure Description 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).
Time Frame 1 hour after treatment  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled patients were analyzed with the intention-to-treat principles.

Reporting Groups
  Description
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

Measured Values
    Conventional     Pantoprazole  
Number of Participants Analyzed  
[units: participants]
 		  44     43  
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment  
[units: millimeter]
Mean ± Standard Deviation 		  17  ± 24     19  ± 23  


Statistical Analysis 1 for Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] 0.6
Mean Difference (Final Values) [4] -2.6
Standard Deviation ± 5.0
95% Confidence Interval ( -12.7 to 7.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null hypothesis is that the treatment with pantoprazole arm is not different in immediate relief of acute, severe dyspeptic pain compared with conventional arm.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Number of Participants in the Predefined "Responders"   [ Time Frame: pretreatment and 1 hour after treatment ]
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3.  Secondary:   Number of Participants in the Predefined "Non-responders"   [ Time Frame: pretreatment and 1 hour after treatment ]
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4.  Secondary:   Number of Participants That Have Overall Satisfaction on the Treatment   [ Time Frame: 1 hour after treatment ]
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5.  Secondary:   Number of Participants With Adverse Effect   [ Time Frame: 1 hour after treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
1. This was a small, single-centered study. 2. Exaggerated self-evaluation of the patients' pain score and the physician’s expectation of a “good outcome” may also have biased the report. 3. The short-term recurrence of the pain was not studied.  


Results Point of Contact:  
Name/Title: Khrongwong Musikatavorn, MD
Organization: Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital.
phone: +662-256-4000 ext 4553-5
e-mail: kmusikatavorn@yahoo.com


Publications of Results:


Responsible Party: Khrongwong Musikatavorn, MD., Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01281501     History of Changes
Other Study ID Numbers: 619/2010
Study First Received: January 17, 2011
Results First Received: April 8, 2012
Last Updated: July 25, 2012
Health Authority: Thailand: Ethical Committee