CompletedPhase 4

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

South Korea39 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time to onset of first 1Day Heartburn free, Days

Timeframe: up to 8 weeks

Trial details

NCT IDNCT01860482

SponsorChong Kun Dang Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05

View on ClinicalTrials.gov More Reflux Esophagitis trials