Gastroesophageal Reflux Treatment in Scleroderma

Last updated: February 3, 2017
Sponsor: Khon Kaen University
Overall Status: Completed

Phase

3

Condition

Heartburn (Pediatric)

Esophageal Disorders

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01878526
GERD therapy in scleroderma
PPI in SSc-GERD
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 weeksbefore baseline evaluation

Exclusion

Exclusion criteria:

  1. Pregnancy or lactation

  2. Previous history of gastroesophageal surgery or endoscopic therapy due to severeerosive 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 orrenal 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 GERDsymptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate Phase 2 randomized parallel study SSc patients who fit all inclusion and exclusion criteriawill be eligible to phase 2 study. Inclusion criteria:

  10. SSc patients who completed the phase 1 study.

  11. The subjects were defined as PPI-resistance.

  12. The subject must be willing to continue phase 2 study. Exclusion criteria:

  13. Pregnancy

  14. Present of uncontrolled or severe medical problems

  15. Present of active infection

  16. Allergic history of alginic acid or domperidone

  17. Receiving prohibit co-medications that may have drug interaction or attenuate GERDsymptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate

  18. Chewing difficulty

Study Design

Total Participants: 80
Study Start date:
June 01, 2013
Estimated Completion Date:
January 31, 2016

Connect with a study center

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

    Khon Kaen, 40002
    Thailand

    Site Not Available

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