Gastroesophageal Reflux Treatment in Scleroderma

Systemic Sclerosis Clinical Trial

— GERD-SSc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01878526
• Other study ID #: GERD therapy in scleroderma
• Secondary ID: PPI in SSc-GERD
• Status: Recruiting
• Phase: Phase 3
• First received: June 7, 2013
• Last updated: September 17, 2015
• Start date: June 2013

Study information

• Verified date: September 2015
• Source: Khon Kaen University
• Contact: Chingching Foocharoen, MD
• Phone: 6643363746
• Email: fching[@]kku.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• Alginic acid
Algycon 1 tab chew tid after meal
• placebo (for domperidone)
placebo (for domperidone) 1 tab oral tid before meal
• Domperidone
domperidone (10 mg) 1 tab oral tid before meal
• placebo (of alginic acid)
placebo (for alginic acid) 1 tab chew tid after meal

Locations

Country	Name	City	State
Thailand	123 Department of Medicine, Faculty of Medicine, Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changing severity of heart burn and regurgitation of SSc related omeprazole resistant GERD evaluated by visual analogue score (VAS)		8 weeks	Yes
Secondary	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)		8 weeks	Yes
Secondary	the prevalence of omeprazole-resistant GERD in SSc after 4 weeks treatment with omeprazole		4 weeks	Yes