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Completed

NCT Number: NCT01860482

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chonnam National University Hospital, Gwangju, Donggu, Jebongro, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.)
  • Pregnant or breast-feeding women
  • Conversation impairment because of alcohol, drug addiction or mental illness, etc.
  • Administration of other IP within 28 days
  • Inability to record heartburn diary card
  • In investigator's judgement

Treatment and study plan

Newrabell® Tablet 10mg

Drug

Other names: Rabeprazole sodium

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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 22, 2013
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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