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

Overview

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.

Full Title of Study: “An 8-weeks, Multicenter, Single Arm, Non-comparative, Phase 4 Clinical Trial to Assess the Efficacy and Safety of Newrabell® Tab. at 10mg b.i.d in Patients With Refractory Reflux Esophagitis(rGERD) to the Prior Standard PPIs Regimen”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2015

Interventions

  • Drug: Newrabell® Tablet 10mg

Arms, Groups and Cohorts

  • Experimental: Newrabell single arm
    • Newrabell® Tablet 10mg b.i.d PO during 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Time to onset of first 1Day Heartburn free, Days
    • Time Frame: up to 8 weeks

Secondary Measures

  • Time to onset of first 2Days Heartburn free, Days
    • Time Frame: up to 8 weeks
  • 1Day Heartburn free days, %
    • Time Frame: up to 8 weeks
  • Time in Daytime of first Heartburn free, Days
    • Time Frame: up to 8 weeks
  • Time in Nighttime of first Heartburn free, Days
    • Time Frame: up to 8 weeks
  • Weekly Heartburn Improvement Rate, %
    • Time Frame: up to 8 weeks
  • Average Daytime and Nighttime Heartburn Score Change at W4
    • Time Frame: up to 8 weeks
  • Average Daytime and Nighttime Heartburn Score Change at W8
    • Time Frame: up to 8 weeks

Participating in This Clinical Trial

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:

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chong Kun Dang Pharmaceutical
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jongsun Rew, Ph.D, Principal Investigator, Chonnam National University Hospital
    • Sungbum Cho, Ph.D, Principal Investigator, Chonnam National University Hospital

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