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Gastroesophageal Reflux Treatment in Scleroderma (GERD-SSc)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chingching Foocharoen, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01878526
First received: June 7, 2013
Last updated: February 3, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Gastroesophageal Reflux Disease
Systemic Sclerosis
Scleroderma
Drug: Alginic acid
Drug: placebo (for domperidone)
Drug: Domperidone
Drug: placebo (of alginic acid)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • 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.

  • 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.


Secondary Outcome Measures:
  • 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.

  • the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole [ Time Frame: 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.


Enrollment: 80
Study Start Date: June 2013
Study Completion Date: January 2016
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omeprazole plus alginic acid and placebo of domperidone Drug: Alginic acid
Algycon 1 tab chew tid after meal
Other Name: 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 Name: Molax
Drug: placebo (of alginic acid)
placebo (for alginic acid) 1 tab chew tid after meal

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878526

Locations
Thailand
123 Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Chingching Foocharoen, MD Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chingching Foocharoen, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01878526     History of Changes
Other Study ID Numbers: GERD therapy in scleroderma
PPI in SSc-GERD ( Other Grant/Funding Number: Thai Rheumatism Association )
Study First Received: June 7, 2013
Results First Received: August 22, 2016
Last Updated: February 3, 2017

Keywords provided by Khon Kaen University:
gastroesophageal reflux disease
heart burn
regurgitation
systemic sclerosis
scleroderma
proton pump inhibitor
alginic acid
omeprazole
prokinetic

Additional relevant MeSH terms:
Sclerosis
Gastroesophageal Reflux
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Connective Tissue Diseases
Skin Diseases
Domperidone
Omeprazole
Alginic acid
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Radiation-Protective Agents
Protective Agents
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on May 22, 2017