NCT02274961

Brief Summary

This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

October 13, 2014

Last Update Submit

October 24, 2014

Conditions

Non Erosive Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease

    4 weeks

Study Arms (2)

S-pantoprazole 10mg

EXPERIMENTAL

S-pantoprazole 10mg Tablet once daily for 4 weeks

Drug: S-pantoprazole 10mg

Placebo

PLACEBO COMPARATOR

Placebo tablet for the test drug

Drug: Placebo

Interventions

S-pantoprazole 10mgDRUG
S-pantoprazole 10mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults between the ages of 19 and 75 inclusive
  • Patient with a history of heartburn or acid regurgitation for at least 3 months.
  • Those with episodes of heartburn for 2 days or more during the last 7 days prior to baseline
  • Patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD) performed within 7 days of screening
  • Capable of providing written informed consent, willing and able to a comply with all procedures of the study

You may not qualify if:

  • History of endoscopic erosive esophagitis(EE) at screening EGD.
  • Historical evidence of the following disease/conditions : symptom of Irritable bowel syndrome
  • More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in the esophagus
  • Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit
  • H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal Antiinflammatory Drugs(NSAIDs) (except low dose aspirin) during the 2 weeks prior to the screening
  • Historical evidence of the following disease/conditions during 3 months: Zollinger-Ellison syndrome, the primary esophageal motility disorders achalasia, esophageal stricture, pancreatitis, gastric ulcer, evidence of upper G.I. malignancy, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, severe liver disease, severe renal disease, cerebral vascular disease,
  • Known hypersensitivity to any component of drug
  • pregnancy or lactation (F only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Yeungnam University Medical Center

Daegu, Daegu, South Korea

RECRUITING

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, South Korea

RECRUITING

Bundang CHA Medical Center

Sung-Nam, Gyeonggi-do, South Korea

RECRUITING

Seoul National University Bundang Hospital

Sung-Nam, Gyeonggi-do, South Korea

RECRUITING

Asan Medical Center

Seoul, Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, Seoul, South Korea

RECRUITING

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, Seoul, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Gastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

JINHYUNG KIM, Senior Researcher

CONTACT

82-2-3289-4362jhkim04@ahn-gook.com

Chulhun Sung, Senior Researcher

CONTACT

82-2-3289-4284sch9013@ahn-gook.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 27, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

KR(10)