Gastroesophageal Reflux Treatment in Scleroderma (GERD-SSc)

February 3, 2017 updated by: Chingching Foocharoen, Khon Kaen University

The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis

The investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • 123 Department of Medicine, Faculty of Medicine, Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Phase 1 SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 1 study for evaluation the prevalence of omeprazole resistant-GERD

Inclusion criteria:

  1. SSc patients aged between 18 and 65 years.
  2. Clinically diagnosed as GERD and GERD-questionnaire score >3
  3. Must not receive any proton pump inhibitor (PPI) or prokinetic drug within 2 weeks before baseline evaluation

Exclusion criteria:

  1. Pregnancy or lactation
  2. Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
  3. Present of Barrett's esophagus
  4. Bedridden and confined to no self-care
  5. Evidence of active malignant disease
  6. Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases
  7. Present of active infection that needs systemic antibiotic
  8. Allergic history of omeprazole
  9. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate

Phase 2 randomized parallel study SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 2 study.

Inclusion criteria:

  1. SSc patients who completed the phase 1 study.
  2. The subjects were defined as PPI-resistance.
  3. The subject must be willing to continue phase 2 study.

Exclusion criteria:

  1. Pregnancy
  2. Present of uncontrolled or severe medical problems
  3. Present of active infection
  4. Allergic history of alginic acid or domperidone
  5. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
  6. Chewing difficulty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omeprazole plus alginic acid and placebo of domperidone
Drug: Alginic acid
Algycon 1 tab chew tid after meal
Other Names:
  • Algycon
Drug: placebo (for domperidone)
placebo (for domperidone) 1 tab oral tid before meal
Experimental: Omeprazole plus domperidone and placebo of alginic acid
Drug: Domperidone
domperidone (10 mg) 1 tab oral tid before meal
Other Names:
  • Molax
Drug: placebo (of alginic acid)
placebo (for alginic acid) 1 tab chew tid after meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)
Time Frame: 8 weeks
VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment.
8 weeks
Changing of the Severity of Regurgitation
Time Frame: 8 weeks
VAS scale 0-100 was applied for an outcome measurement of the severity of regurgitation. The VAS scale 0 was no symptoms of regurgitation and scale 100 was a maximum symptom of regurgitation. The changing of the severity of regurgitation was the changing of VAS before and after treatment.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)
Time Frame: 8 weeks
Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment.
8 weeks
the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole
Time Frame: 4 weeks
4 weeks
Changing of the Quality of Life Which is Evaluated by EQ-5DTM
Time Frame: 8 weeks
VAS scale 0-100 was applied for an outcome measurement of the quality of life. The VAS scale 0 was the worst quality of life and scale 100 was the best quality of life. The changing of the quality of life was the changing of VAS of quality of life before and after treatment.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Chingching Foocharoen, MD, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GERD therapy in scleroderma
  • PPI in SSc-GERD (Other Grant/Funding Number: Thai Rheumatism Association)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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