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A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment

Primary Purpose

Dyspepsia

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Alginate
Sucralfate
Hydrotalcite
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Dyspepsia, Emergency Department, Antacid, Viscous Lidocaine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stomach pain, swelling or dispeptic complaints.
  • Men and women between the ages of 18-60.
  • Patients with VAS> 5.

Exclusion Criteria:

  • Pregnancy and lactation.
  • Sucralfate, alginate, hydrotalcite allergy.
  • Emergency service arrives with acute psychiatric symptoms.
  • Gastrointestinal system bleedings.
  • Chronic renal failure, liver cirrhosis, structural and functional heart disease.
  • Gastric malignancy and terminal illness.
  • Patients suspected of having a different problem such as ileus, biliary colic,
  • pancreatitis, hepatitis.
  • Patients who refuse to participate in the study.
  • Those who can not use VAS.
  • Presence of ischemic findings on the arrival ECG.

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Alginate

Sucralfate

Hydrotalcite

Arm Description

10 cc of Alginate peroral

10 cc of Sucralfate peroral

10 cc of Hydrotalcite peroral

Outcomes

Primary Outcome Measures

Relief of Gastric Pain
Compare relief of dispeptic complaint with using VAS (Visual Analog Scale) in 3 groups of alginate, sucralfate and hydrotalcite patients. Patients' pain scores were recorded using 0-100 mm VAS (Visual Analog Scale) to score the degree of dyspeptic complaints. VAS; It is composed of a measured horizontal or vertical line and often carries definitions of "no symptoms" on one end and "severe symptoms" on the other end. The patient is told to mark a point on the line according to the severity of the symptom. The location of the marker allows the severity of the symptom to be measured. The VAS markings on the evaluation forms prepared for the study before and during the procedure were made by the patient himself and regardless of the previous sign. Patients with VAS> 50 were treated. Patients were observed for 60 minutes in the emergency department and 60-minute VAS (Visual Analog Scale) score above 50 were given to the patient for rescue treatment.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2018
Last Updated
August 29, 2018
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT03635372
Brief Title
A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment
Official Title
A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment: Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
October 22, 2017 (Actual)
Study Completion Date
November 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dyspepsia is a very common but non-specific complaint that may indicate a group of symptoms that can be attributed to the upper gastrointestinal system, such as epigastric discomfort, abdominal bloating or fullness, stomach upset and nausea or vomiting that may be associated with food. This study aimed to improve treatment management of patients with complaints of dyspeptic pain and emergency services, and to compare treatment efficacy of oral sucralfate, alginate and hydrotalcite, which are widely used in our country. Literature According to our research, our study is the first study to compare different antacids in our study of emergency serviste dyspepsia.
Detailed Description
This study was performed prospectively, randomly, controlled, double-blind to compare the efficacy of oral sucralfate, alginate and hydrotalcite in patients presenting with emergency department dyspeptic complaints at Pamukkale University Medical Faculty Hospital Emergency Medicine Department. Patients who were referred to the emergency department with stomach ache or dyspeptic complaints were taken to the study. Treatment medicines were applied according to the randomization scheme of the study patients. This study was carried out in Pamukkale University Faculty of Medicine Emergency Medicine Department during 8 months between 01.03.2016 and 30.10.2016. Approximately 98,000 adult patients / year in the emergency department have a research assistant and / or faculty member who will check the research as a 24-hour primer. This study included 300 cases between 18 and 60 years of age who were admitted to our emergency department with dispeptic complaints, agreed to participate in the study, informed consent, and met inclusion criteria. The criteria for receiving and not receiving work were specified at the beginning of the study. When appropriate patients were admitted to the study, the patient was taken to the emergency monitoring monitor and monitored once the written consent was obtained. Patients were assigned to one of the study groups according to the study number, according to the randomization scheme prepared by a non-emergency service computer. The numbers for the previously numbered workgroups were kept in unmarked envelopes and the envelope was opened by the study nurse to prepare the study medicine. The study medicines were prepared by an independent person who did not participate in the study or by the responsible work nurse who was at the helpline and was given to the patient by the other nurse. For each group, the drugs prepared in a 10 cc syringe were wrapped around the syringe with a color patch that did not show any similarity. When the medication was given to the patient, the patient's nose was closed and the drug smell was not taken. Patients were observed for 30 minutes in the emergency department and 30-minute VAS (Visual Analog Scale) score 5 and above were given to the patient for rescue treatment. The information and data of the patients were collected by questionnaire. In the first part of the questionnaire, patients' demographic information address, telephone numbers, medical backgrounds, medications and vital findings were recorded. Detailed physical examinations of all patients were evaluated by emergency physician. Patients diagnosed with dyspepsia other than dyspepsia such as acute coronary syndrome, pancreatitis, cholecystitis, acute abdomen, ileus, malignancy and gastroenteritis were excluded as a result of history and physical examination. Patients who did not give their consent to participate were also excluded from the study. The patient with unexplained dyspepsia was directed to the gastroenterology polyclinic for endoscopy with necessary information. After discharge, patients were asked whether they had recurring epigastric pain within 24 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Dyspepsia, Emergency Department, Antacid, Viscous Lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alginate
Arm Type
Experimental
Arm Description
10 cc of Alginate peroral
Arm Title
Sucralfate
Arm Type
Experimental
Arm Description
10 cc of Sucralfate peroral
Arm Title
Hydrotalcite
Arm Type
Experimental
Arm Description
10 cc of Hydrotalcite peroral
Intervention Type
Drug
Intervention Name(s)
Alginate
Other Intervention Name(s)
Gaviscon Lipuid
Intervention Description
10 cc of Alginate peroral
Intervention Type
Drug
Intervention Name(s)
Sucralfate
Other Intervention Name(s)
Antepsin Suspension
Intervention Description
10 cc of Sucralfate peroral
Intervention Type
Drug
Intervention Name(s)
Hydrotalcite
Other Intervention Name(s)
Talcid Suspension
Intervention Description
10 cc of Hydrotalcite peroral
Primary Outcome Measure Information:
Title
Relief of Gastric Pain
Description
Compare relief of dispeptic complaint with using VAS (Visual Analog Scale) in 3 groups of alginate, sucralfate and hydrotalcite patients. Patients' pain scores were recorded using 0-100 mm VAS (Visual Analog Scale) to score the degree of dyspeptic complaints. VAS; It is composed of a measured horizontal or vertical line and often carries definitions of "no symptoms" on one end and "severe symptoms" on the other end. The patient is told to mark a point on the line according to the severity of the symptom. The location of the marker allows the severity of the symptom to be measured. The VAS markings on the evaluation forms prepared for the study before and during the procedure were made by the patient himself and regardless of the previous sign. Patients with VAS> 50 were treated. Patients were observed for 60 minutes in the emergency department and 60-minute VAS (Visual Analog Scale) score above 50 were given to the patient for rescue treatment.
Time Frame
Change from baseline in dispeptic complaint VAS scores at 60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stomach pain, swelling or dispeptic complaints. Men and women between the ages of 18-60. Patients with VAS> 5. Exclusion Criteria: Pregnancy and lactation. Sucralfate, alginate, hydrotalcite allergy. Emergency service arrives with acute psychiatric symptoms. Gastrointestinal system bleedings. Chronic renal failure, liver cirrhosis, structural and functional heart disease. Gastric malignancy and terminal illness. Patients suspected of having a different problem such as ileus, biliary colic, pancreatitis, hepatitis. Patients who refuse to participate in the study. Those who can not use VAS. Presence of ischemic findings on the arrival ECG.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulgun Battal, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment

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