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

NCT03561233 | Completed Phase 1 DMC

• 1 other identifier: PPI partial response GERD SSc
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Changing severity of heart burn of SSc related GERD evaluated by visual analogue score (VAS) Changing Severity of Heart Burn of SSc Evaluated by Visual Analogue Score (VAS)

  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. PPI-PR GERD is defined when the changing of severity of heart burn is improvement less than 50% compare to baseline.

  4 weeks

• Changing of Frequency of Symptoms in SSc related GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)

  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. PPI-PR GERD is defined when the changing of frequency of symptom in SSc related GERD evaluated by FSSG is improvement less than 50% compare to baseline.

  4 weeks

Secondary Outcomes (6)

• The proportion of participant with diffuse cutaneous SSc (dcSSc) subset between the patient who response to omeprazole and partial response to omeprazole,

  4 weeks

• The proportion of participant with esophageal dysphagia between the patient who response to omeprazole and partial response to omeprazole,

  4 weeks

• The proportion of participant with female gender between the patient who response to omeprazole and partial response to omeprazole

  4 weeks

• The proportion of participant with age>60 years between the patient who response to omeprazole and partial response to omeprazole

  4 weeks

• The proportion of participant with modified Rodnan skin score (mRSS)>20 between the patient who response to omeprazole and partial response to omeprazole

  4 weeks

Study Arms (1)

proton pump inhibitor

EXPERIMENTAL

omeprazole 20 mg twice daily

Drug: Omeprazole 20mg

Interventions

Omeprazole 20mg DRUG

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

proton pump inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SSc patients aged between 18 and 65 years.
• Clinically diagnosed as GERD
• Must not receive any PPI or prokinetic drug within 2 weeks before baseline evaluation

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead
• Thai Rheumatism Association: collaborator

MeSH Terms

Conditions

Scleroderma, Systemic; Gastroesophageal Reflux

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 19, 2018
• Study Start: May 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 21, 2018

Record last verified: 2018-06