A clinical trial to evaluate the efficacy and safety of PPI/sodium alginate therapy compared with PPI in nonerosive reflux disease

A randomized, double-blind, Multi-center clinical trial to evaluate the efficacy and safety of combination PPI/sodium alginate and PPI in Nonerosive Reflux Disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002297

Enrollment

120

Registered

2017-04-05

Start date

2014-07-29

Completion date

Unknown

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 3 arms (Control arm) PPI monotherapy group: [Omeprazole 20mg, 1 time/day, before meal (breakfast) + Placebo alginic acid 20mL/time, 3~4 times/day, between meals] x 4weeks (Test arm) PPI+Alginat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) age of 20 ~ 79 years old 2) NERD patient suffering heartburn or regrugitation(either one) in past 7 days over 2 days of moderate to severe level or over 4 days of mild symptoms 3) volentary agreement with signed informed consent

Exclusion criteria

Exclusion criteria: 1) esophageal stricture, hietal hernea, Barrett's esophagus 2) active gastro-esophageal ulcer or bleeding under treatement or history not reaching scar stage 3) uncontrolled hypertension (>140/90mmHg) 4) clinically meaningful kidney or liver dysfunction (serum creatinine>1.5mg/dl, >2.5 times of normal AST/ALT level) 5) treatment history with H2-blocker, prostaglandine derivatives, mucoprotective agents, prokinetics for more than 5 consecutive days within last 2 weeks or any within 3 days 6) PPI treatment history within last 2 weeks 7) any conditions to take NSAIDs(nonsteroidal anti-inflammatory drugs) or steroids or aspirin consecutively during study period 8) surgery history to influence gastric acid secretion 9) known hypersensitivity to study medications of sodium alginate, omeprazole 10) cancer history within 5 years 11) pregnancy or lactation (including pregnancy possibility) during study period 12) alcohol or drug addiction 13) other clinical study participants within 30 days 14) investigator's judge of inappropiation

Design outcomes

Primary

Measure	Time frame
resolution of NERD symptom in the last 7 consecutive days (%, patient diary)	—

Secondary

Measure	Time frame
Changes of NERD symptom score (patient diary);NERD symptom free days during 4 treatment weeks (%, patient diary);overnight NERD symptom free days during 4 treatment weeks (%, patient diary);Reflux-Disease-Questionnair(RDQ) survey score change;Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life(PAGI-QOL) survey score change;Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) survey score change;Investigator's assessment for NERD symptom	—

Measure

Time frame

Changes of NERD symptom score (patient diary);NERD symptom free days during 4 treatment weeks (%, patient diary);overnight NERD symptom free days during 4 treatment weeks (%, patient diary);Reflux-Disease-Questionnair(RDQ) survey score change;Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life(PAGI-QOL) survey score change;Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) survey score change;Investigator's assessment for NERD symptom

—

Countries

Korea, Republic of

Contacts

Public ContactYong Chan Lee

Yonsei University

leeyc@yuhs.ac+82-2-2228-1960

Outcome results