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Completed

NCT Number: NCT01878526

Gastroesophageal Reflux Treatment in Scleroderma

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Exclusion criteria

  • Pregnancy or lactation
  • Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
  • Present of Barrett's esophagus
  • Bedridden and confined to no self-care
  • Evidence of active malignant disease
  • Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases
  • Present of active infection that needs systemic antibiotic
  • Allergic history of omeprazole
  • 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

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

Exclusion criteria

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

Treatment and study plan

Alginic acid

Drug

Algycon 1 tab chew tid after meal

Other names: Algycon

placebo (for domperidone)

Drug

placebo (for domperidone) 1 tab oral tid before meal

Domperidone

Drug

domperidone (10 mg) 1 tab oral tid before meal

Other names: Molax

placebo (of alginic acid)

Drug

placebo (for alginic acid) 1 tab chew tid after meal

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole

    Time frame: 4 weeks

  3. 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.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Acronym: GERD-SSc

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 17, 2013
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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