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Completed

NCT Number: NCT01281501

Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

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).

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Key information

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emergency Medicine Unit, King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 11130, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

10 ml of 0.9% sodium chloride solution

Pantoprazole

Drug

80 mg of intravenous pantoprazole

Other names: Controloc (Protonix)

Oral antacid

Drug

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

Other names: Antacid

Hyoscine Butylbromide

Drug

20 mg of intravenous hyoscine butylbromide

Other names: Buscopan

Primary outcomes

  1. Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment

    Time frame: 1 hour after treatment

    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).

Secondary outcomes

  1. Number of Participants in the Predefined "Responders"

    Time frame: 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.

  2. Number of Participants in the Predefined "Non-responders"

    Time frame: 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.

  3. Number of Participants With Adverse Effect

    Time frame: 1 hour after treatment

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

  4. Number of Participants That Have Overall Satisfaction on the Treatment

    Time frame: 1 hour after treatment

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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 24, 2011
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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