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

NCT03635372 | Completed Phase 4 DMC

• 1 other identifier: 2016TPF001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspepsia

Keywords

Dyspepsia; Emergency Department; Antacid; Viscous Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline in dispeptic complaint VAS scores at 60 minutes

Study Arms (3)

Alginate

EXPERIMENTAL

10 cc of Alginate peroral

Drug: Alginate

Sucralfate

EXPERIMENTAL

10 cc of Sucralfate peroral

Drug: Sucralfate

Hydrotalcite

EXPERIMENTAL

10 cc of Hydrotalcite peroral

Drug: Hydrotalcite

Interventions

Alginate DRUG

10 cc of Alginate peroral

Also known as: Gaviscon Lipuid

Alginate

Sucralfate DRUG

10 cc of Sucralfate peroral

Also known as: Antepsin Suspension

Sucralfate

Hydrotalcite DRUG

10 cc of Hydrotalcite peroral

Also known as: Talcid Suspension

Hydrotalcite

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dyspepsia; Emergencies

Interventions

Alginates; Sucralfate; hydrotalcite

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates; Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Sugars

Study Officials

• Gulgun Battal, MD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: June 20, 2017
• Primary Completion: October 22, 2017
• Study Completion: November 25, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)