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Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

NCT ID: NCT01281501

Last Updated: 2013-09-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-10-31

Brief Summary

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The purpose of this study is to evaluate the immediate synergistic effect on the relief of severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of oral antacid and antispasmodic agent (the conventional treatment).

Detailed Description

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Acid-related dyspepsia is common among the population. Number of these patients may have so severe symptoms that can lead them to the emergency department. Mixtures of antacid and antispasmodic were widely used over decades to relieve this acute pain with moderate, yet questionable, improvement in pain score. Proton pump inhibitors (PPIs), the novel acid-lowering agents, are undoubtedly effective to reduce acid secretion and control dyspeptic symptoms in short-term and long-term duration. To our knowledge, no previous study was conducted to evaluate the efficacy of such agents on immediate pain relief in patients with severe dyspeptic symptoms in emergency care. Clinically, they are frequently used to treat this circumstance in an unofficial manner since intravenous proton pump inhibitor alone is not yet considered as a well-approved indication to alleviate such condition. Pantoprazole, a proton pump inhibitor, reaches its peak serum concentration within one hour and its acid-lowering effect occurred within first hour following a single intravenous infusion. Thus, it theoretically has rapid onset and prolonged action on acid reduction. Our primary aim of the study is to evaluate the immediate effect of intravenous pantoprazole in addition to the combination of oral antacid and antispasmodic agent (the conventional regimen) on the relief of severe acid-related dyspeptic pain.

Conditions

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Dyspepsia Emergency Pain

Keywords

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Dyspepsia Emergency treatment Pantoprazole Antacid Pain measurement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Conventional

Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

10 ml of 0.9% sodium chloride solution

Oral antacid

Intervention Type DRUG

30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)

Hyoscine butylbromide

Intervention Type DRUG

20 mg of intravenous hyoscine butylbromide

Pantoprazole

Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole

Group Type EXPERIMENTAL

Pantoprazole

Intervention Type DRUG

80 mg of intravenous pantoprazole

Oral antacid

Intervention Type DRUG

30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)

Hyoscine butylbromide

Intervention Type DRUG

20 mg of intravenous hyoscine butylbromide

Interventions

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Normal saline

10 ml of 0.9% sodium chloride solution

Intervention Type DRUG

Pantoprazole

80 mg of intravenous pantoprazole

Intervention Type DRUG

Oral antacid

30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)

Intervention Type DRUG

Hyoscine butylbromide

20 mg of intravenous hyoscine butylbromide

Intervention Type DRUG

Other Intervention Names

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Controloc (Protonix) Antacid Buscopan

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of acid-related dyspepsia
* age 15 to 50 years

Exclusion Criteria

* pre-treatment 100-millimeter linear Visual Analog Scale (100-mm VAS) pain scores less than 5.0
* known cases of malignancies or terminal illnesses
* known cases of major medical problems
* allergic to studied drugs
* contraindicated to hyoscine butylbromide (glaucoma, myasthenia gravis, paralytic ileus, pyloric stenosis, prostatic enlargement, porphyria)
* received acid antisecretory agents (proton pump inhibitors or histamine-2 receptor antagonists), antispasmodic agents, alcoholic consumption, nonsteroidal anti-inflammatory drugs, aspirin and steroids within 5 days or oral antacids within 4 hours prior to the visit
* receiving clopidogrel, statins, iron therapies, warfarins, antiretroviral agents, which may have serious drug interaction with the proton pump inhibitors
* receiving drugs that have strong anticholinergic activities (e.g. acetylcholinesterase inhibitors for Parkinson's or Alzheimer diseases, antihistamines, antispasmodic agents, antipsychotics, skeletal muscle relaxants, tricyclic antidepressants) or decongestants, which may have serious drug interaction with hyoscine butylbromide
* suspected other alternative diagnoses (e.g. gut obstruction, biliary colic, pancreatitis, hepatitis or localized hepatobiliary infections, etc.)
* pregnancy or breast-feeding participants
* did not comprehend the Visual Analog Scale (VAS) evaluation
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Khrongwong Musikatavorn, MD.

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khrongwong Musikatavorn, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Emergency Medicine Unit, King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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Musikatavorn K, Tansangngam P, Lumlertgul S, Komindr A. A randomized controlled trial of adding intravenous pantoprazole to conventional treatment for the immediate relief of dyspeptic pain. Am J Emerg Med. 2012 Nov;30(9):1737-42. doi: 10.1016/j.ajem.2012.02.001. Epub 2012 Mar 29.

Reference Type RESULT
PMID: 22463973 (View on PubMed)

Other Identifiers

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619/2010

Identifier Type: -

Identifier Source: org_study_id