Gastroesophageal Reflux Treatment in Scleroderma (GERD-SSc)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Khon Kaen University
Sponsor:
Information provided by (Responsible Party):
Chingching Foocharoen, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01878526
First received: June 7, 2013
Last updated: September 24, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 and regurgitation of SSc related omeprazole resistant GERD evaluated by visual analogue score (VAS) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • changing of frequency of symptoms in SSc related omeprazole resistant GERD evaluated by frequency scale for the symptoms of GERD (FSSG) and the quality of life which is evaluated by EQ-5DTM (by EuroQol Group) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • the prevalence of omeprazole-resistant GERD in SSc after 4 weeks treatment with omeprazole [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: June 2013
Estimated Primary Completion Date: December 2019 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Chingching Foocharoen, MD 6643363746 fching@kku.ac.th

Locations
Thailand
123 Department of Medicine, Faculty of Medicine, Khon Kaen University Recruiting
Khon Kaen, Thailand, 40002
Contact: Chingching Foocharoen, MD    6643363746    fching@kku.ac.th   
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

No publications provided

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
Study First Received: June 7, 2013
Last Updated: September 24, 2013
Health Authority: Thailand: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014