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Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860624
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Livzon Pharmaceutical Group Inc.

Brief Summary:
This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: 10 mg ilaprazole Drug: 40mg esomeprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ilaprazole for GERD: A Randomized, Double-Blind, Esomeprazole-Controlled, Phase 3, Multicenter Trial in China
Study Start Date : December 2011
Actual Primary Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: 10 mg ilaprazole Drug: 10 mg ilaprazole
Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) being taken orally each morning on an empty stomach for 8 weeks

Active Comparator: 40 mg esomeprazole Drug: 40mg esomeprazole
One 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks




Primary Outcome Measures :
  1. Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels. [ Time Frame: week 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consenting patients will be eligible for enrollment if they:
  • are 18-70 years of age,
  • have at least one of the two symptoms, heartburn and reflux,
  • have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.

Exclusion Criteria:

  • Patients will be ineligible if they:
  • have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
  • have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
  • have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
  • have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
  • participated in a clinical trial with an investigational drug or device within the past three months,
  • have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,
  • have alcoholic intemperance, drug addiction or any other improper habits.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT02860624    
Other Study ID Numbers: Livzon-IY-81149R-11-01
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: July 2016
Keywords provided by Livzon Pharmaceutical Group Inc.:
GERD
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action