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Gastroesophageal Reflux Treatment in Scleroderma (GERD-SSc)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01878526
First Posted: June 17, 2013
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chingching Foocharoen, Khon Kaen University
  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: Quadruple (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 Chingching Foocharoen, 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

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Submitted: June 7, 2013
First Posted: June 17, 2013
Results First Submitted: August 22, 2016
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017
Last Verified: February 2017

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

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