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: September 9, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention Phase
Dyspepsia
Emergency
Pain
Drug: Normal saline
Drug: Pantoprazole
Drug: Oral antacid
Drug: Hyoscine butylbromide
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment [ Time Frame: 1 hour after treatment ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Participants in the Predefined "Responders" [ Time Frame: pretreatment and 1 hour after treatment ] [ Designated as safety issue: No ]
    "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.

  • Number of Participants in the Predefined "Non-responders" [ Time Frame: pretreatment and 1 hour after treatment ] [ Designated as safety issue: No ]
    "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.

  • Number of Participants With Adverse Effect [ Time Frame: 1 hour after treatment ] [ Designated as safety issue: Yes ]
    The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.

  • Number of Participants That Have Overall Satisfaction on the Treatment [ Time Frame: 1 hour after treatment ] [ Designated as safety issue: No ]
    The satisfaction will be assessed by a simple, self-reported yes/no question.


Enrollment: 87
Study Start Date: January 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional
Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
Drug: Normal saline
10 ml of 0.9% sodium chloride solution
Drug: Oral antacid
30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)
Other Name: Antacid
Drug: Hyoscine butylbromide
20 mg of intravenous hyoscine butylbromide
Other Name: Buscopan
Experimental: Pantoprazole
Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Drug: Pantoprazole
80 mg of intravenous pantoprazole
Other Name: Controloc (Protonix)
Drug: Oral antacid
30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)
Other Name: Antacid
Drug: Hyoscine butylbromide
20 mg of intravenous hyoscine butylbromide
Other Name: Buscopan

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281501

Locations
Thailand
Emergency Medicine Unit, King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, Thailand, 11130
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Khrongwong Musikatavorn, MD Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
  More Information

Publications:
Responsible Party: Khrongwong Musikatavorn, MD., Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital., 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: September 9, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
Dyspepsia
Emergency treatment
Pantoprazole
Antacid
Pain measurement

Additional relevant MeSH terms:
Emergencies
Dyspepsia
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Pantoprazole
Anti-Ulcer Agents
Antacids
Butylscopolammonium Bromide
Scopolamine Hydrobromide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Adjuvants, Anesthesia
Central Nervous System Agents
Mydriatics

ClinicalTrials.gov processed this record on September 16, 2014