NCT01860482

Brief Summary

The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients with refractory reflux esophagitis to the prior standard PPIs regimen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2013

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

2.1 years

First QC Date

May 20, 2013

Last Update Submit

September 22, 2015

Conditions

Reflux Esophagitis

Keywords

Refractory Reflux EsophagitisGERDPhase 4

Outcome Measures

Primary Outcomes (1)

  • Time to onset of first 1Day Heartburn free, Days

    up to 8 weeks

Secondary Outcomes (7)

  • Time to onset of first 2Days Heartburn free, Days

    up to 8 weeks

  • 1Day Heartburn free days, %

    up to 8 weeks

  • Time in Daytime of first Heartburn free, Days

    up to 8 weeks

  • Time in Nighttime of first Heartburn free, Days

    up to 8 weeks

  • Weekly Heartburn Improvement Rate, %

    up to 8 weeks

  • +2 more secondary outcomes

Study Arms (1)

Newrabell single arm

EXPERIMENTAL

Newrabell® Tablet 10mg b.i.d PO during 8 weeks

Drug: Newrabell® Tablet 10mg

Interventions

Newrabell® Tablet 10mgDRUG
Also known as: Rabeprazole sodium
Newrabell single arm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female aged ≥ 20 years
  • Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam.
  • Refractory reflux esophagitis to PPIs standard treatment as follows
  • Ongoing heartburn symptom with or without these GERD-related symptoms : Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating, Satiety, Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia, Odynophagia, Weight loss
  • Ongoing heartburn symptom with or without erosion ≥ grade A according to LA Classification
  • Ongoing heartburn symptoms ≥ 2 days during 1week right before administering first dose of IP
  • Decided to participate and signed on an informed consent form willingly

You may not qualify if:

  • Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening
  • History of operation in esophagus, stomach or duodenum
  • The following medical history
  • Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/pyloric stricture, Primary esophageal spasm
  • Barrett's esophagus ≥ 3 cm
  • Zollinger-Ellison syndrome
  • Infectious or inflammatory bowel disease, Severe malabsorption
  • Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis
  • History of cancer within 5 years, except completely recovered skin cancer
  • ALT or AST ≥ Upper limit of normal range X 3
  • Need antibiotics due to severe infection
  • Severe medical disease that needs these prohibited medication
  • Anticoagulant(Heparin, Warfarin, etc.), High dose of aspirin(\>325mg/d), Digitalis(Digoxin, etc.), Diuretics, Atazanavir, NSAIDs or Steroids
  • Use PPIs or H2RA medicine within 1 week before administering first dose of IP, or need other PPIs or H2RA medicine during trial period
  • Allergy or hypersensitivity to IP or similar chemical structure(Benzimidazol derivatives, etc.)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chonnam National University Hospital

Gwangju, Donggu, Jebongro, 501-757, South Korea

Location

Chonnam National University Hwasun Hospital

Gwangju, Hwasun-eup,Hwasun-gun, 519-763, South Korea

Location

MeSH Terms

Conditions

Esophagitis, PepticGastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach DiseasesEsophageal Motility DisordersDeglutition Disorders

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jongsun Rew, Ph.D

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

  • Sungbum Cho, Ph.D

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations

KR(2)