Clinical trial NCT01878526: Gastroesophageal Reflux Treatment in Scleroderma
Official title: The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Systemic Sclerosis
Scleroderma
Keywords: gastroesophageal reflux disease
heart burn
regurgitation
systemic sclerosis
scleroderma
proton pump inhibitor
alginic acid
omeprazole
prokinetic
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)
timeFrame: 8 weeks
measure: Changing of the Severity of Regurgitation
timeFrame: 8 weeks
Secondary outcomes:
measure: Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)
timeFrame: 8 weeks
measure: the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole
timeFrame: 4 weeks
measure: Changing of the Quality of Life Which is Evaluated by EQ-5DTM
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: 123 Department of Medicine, Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
name: Chingching Foocharoen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foocharoen C, Chunlertrith K, Mairiang P, Mahakkanukrauh A, Suwannaroj S, Namvijit S, Wantha O, Nanagara R. Effectiveness of add-on therapy with domperidone vs alginic acid in proton pump inhibitor partial response gastro-oesophageal reflux disease in systemic sclerosis: randomized placebo-controlled trial. Rheumatology (Oxford). 2017 Feb;56(2):214-222. doi: 10.1093/rheumatology/kew216. Epub 2016 May 13.