DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

Information source: Chulalongkorn University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyspepsia; Emergency; Pain

Intervention: Normal saline (Drug); Pantoprazole (Drug); Oral antacid (Drug); Hyoscine butylbromide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Chulalongkorn University

Official(s) and/or principal investigator(s):
Khrongwong Musikatavorn, MD, Principal Investigator, Affiliation: Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital

Summary

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

Number of Participants in the Predefined "Responders"

Number of Participants in the Predefined "Non-responders"

Number of Participants With Adverse Effect

Number of Participants That Have Overall Satisfaction on the Treatment

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

Minimum age: 15 Years. Maximum age: 50 Years. Gender(s): Both.

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

Locations and Contacts

Emergency Medicine Unit, King Chulalongkorn Memorial Hospital, Patumwan, Bangkok 11130, Thailand
Additional Information

Starting date: January 2011
Last updated: September 9, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017