Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis

NCT ID: NCT03561233

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-06-30

Brief Summary

Proton pump inhibitor (PPI) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (GERD)-is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.

Conditions

Systemic Sclerosis; Gastroesophageal Reflux; Proton Pubm Inhibitor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

proton pump inhibitor

omeprazole 20 mg twice daily

Group Type: EXPERIMENTAL

Omeprazole 20mg

Intervention Type: DRUG

omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks

Interventions

Omeprazole 20mg

omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. SSc patients aged between 18 and 65 years.

2. Clinically diagnosed as GERD

3. Must not receive any 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thai Rheumatism Association

UNKNOWN

Sponsor Role: collaborator

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Chingching Foocharoen

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PPI partial response GERD SSc

Identifier Type: -

Identifier Source: org_study_id