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CompletedNCT01860482Updated Sep 24, 2015

The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD

A Phase 4 interventional study of Newrabell® Tablet 10mg in Reflux Esophagitis, sponsored by Chong Kun Dang Pharmaceutical. Completed at 2 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-09-24.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Reflux Esophagitis

Keywords

  • Refractory Reflux Esophagitis
  • GERD
  • Phase 4
03

In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 38 are open to participants now.

This study's enrollment of 39 is below the median of 66 across 215 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or Female aged ≥ 20 years
  2. Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam.
  3. Refractory reflux esophagitis to PPIs standard treatment as follows

    1. 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
    2. Ongoing heartburn symptom with or without erosion ≥ grade A according to LA Classification
  4. Ongoing heartburn symptoms ≥ 2 days during 1week right before administering first dose of IP
  5. Decided to participate and signed on an informed consent form willingly

Exclusion criteria

Exclusion Criteria:

  1. Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening
  2. History of operation in esophagus, stomach or duodenum
  3. The following medical history

    1. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/pyloric stricture, Primary esophageal spasm
    2. Barrett's esophagus ≥ 3 cm
    3. Zollinger-Ellison syndrome
    4. Infectious or inflammatory bowel disease, Severe malabsorption
  4. Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis
  5. History of cancer within 5 years, except completely recovered skin cancer
  6. ALT or AST ≥ Upper limit of normal range X 3
  7. Need antibiotics due to severe infection
  8. 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
  9. Use PPIs or H2RA medicine within 1 week before administering first dose of IP, or need other PPIs or H2RA medicine during trial period
  10. Allergy or hypersensitivity to IP or similar chemical structure(Benzimidazol derivatives, etc.)
  11. Pregnant or breast-feeding women
  12. Conversation impairment because of alcohol, drug addiction or mental illness, etc.
  13. Administration of other IP within 28 days
  14. Inability to record heartburn diary card
  15. In investigator's judgement
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    Newrabell single arm

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

    Drug: Newrabell® Tablet 10mg

Interventions

  • DrugNewrabell® Tablet 10mg

    Also known as: Rabeprazole sodium

06

What researchers measure

Primary outcomes

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

    Time frame: up to 8 weeks

Secondary outcomes

  1. Time to onset of first 2Days Heartburn free, Days

    Time frame: up to 8 weeks

  2. 1Day Heartburn free days, %

    Time frame: up to 8 weeks

  3. Time in Daytime of first Heartburn free, Days

    Time frame: up to 8 weeks

  4. Time in Nighttime of first Heartburn free, Days

    Time frame: up to 8 weeks

  5. Weekly Heartburn Improvement Rate, %

    Time frame: up to 8 weeks

  6. Average Daytime and Nighttime Heartburn Score Change at W4

    Time frame: up to 8 weeks

  7. Average Daytime and Nighttime Heartburn Score Change at W8

    Time frame: up to 8 weeks

07

Study locations

2 sites
  • Chonnam National University Hospital
    Gwangju, Donggu, Jebongro 501-757, Korea, Republic of
  • Chonnam National University Hwasun Hospital
    Gwangju, Hwasun-eup,Hwasun-gun 519-763, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01860482
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
May 22, 2013
Start date
Apr 2013
Primary completion
May 2015
Completion
May 2015
Last update
Sep 24, 2015

Study contacts

Jongsun Rew, Ph.D
principal investigator · Chonnam National University Hospital
Sungbum Cho, Ph.D
principal investigator · Chonnam National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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