Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole

NCT01281501 | Completed Phase 4 Results

• 1 other identifier: 619/2010
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dyspepsia; Emergency; Pain

Keywords

Dyspepsia; Emergency treatment; Pantoprazole; Antacid; Pain measurement

Outcome Measures

Primary Outcomes (1)

• Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 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).

  1 hour after treatment

Secondary Outcomes (4)

• Number of Participants in the Predefined "Responders"

  pretreatment and 1 hour after treatment

• Number of Participants in the Predefined "Non-responders"

  pretreatment and 1 hour after treatment

• Number of Participants With Adverse Effect

  1 hour after treatment

• Number of Participants That Have Overall Satisfaction on the Treatment

  1 hour after treatment

Study Arms (2)

Conventional

ACTIVE COMPARATOR

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

Drug: Normal saline; Drug: Oral antacid; Drug: Hyoscine butylbromide

Pantoprazole

EXPERIMENTAL

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

Drug: Pantoprazole; Drug: Oral antacid; Drug: Hyoscine butylbromide

Interventions

Normal saline DRUG

10 ml of 0.9% sodium chloride solution

Conventional

Pantoprazole DRUG

80 mg of intravenous pantoprazole

Also known as: Controloc (Protonix)

Pantoprazole

Oral antacid DRUG

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

Also known as: Antacid

Conventional; Pantoprazole

Hyoscine butylbromide DRUG

20 mg of intravenous hyoscine butylbromide

Also known as: Buscopan

Conventional; Pantoprazole

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Emergency Medicine Unit, King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 11130, Thailand

Location

Related Publications (1)

• 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.

  PMID: 22463973 RESULT

MeSH Terms

Conditions

Dyspepsia; Emergencies; Pain

Interventions

Saline Solution; Pantoprazole; Antacids; Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Gastrointestinal Agents; Therapeutic Uses; Quaternary Ammonium Compounds; Amines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

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

• Title: Khrongwong Musikatavorn, MD
• Organization: Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital.

kmusikatavorn@yahoo.com

+662-256-4000

Study Officials

• Khrongwong Musikatavorn, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital.

Study Record Dates

• First Submitted: January 17, 2011
• First Posted: January 24, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: September 18, 2013
• Results First Posted: July 27, 2012

Record last verified: 2013-09

Locations

TH (1)