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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Livzon Pharmaceutical Group Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier:
NCT01107938
First received: April 19, 2010
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention Phase
Gastroesophageal Reflux Disease
 Drug: 10 mg ilaprazole
Drug: 15 mg ilaprazole
Drug: 40 mg esomeprazole
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ilaprazole for GERD: A Randomized,Double-Blind, Esomeprazole-Controlled,Phase2,Multicenter Trial in China

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by Livzon Pharmaceutical Group Inc.:

Primary Outcome Measures:
  • the proportion of patients with healed esophagitis at week 8 [ Time Frame: week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the proportion of patients healed at week 4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • resolution of clinical symptoms [ Time Frame: week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: May 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mg ilaprazole Drug: 10 mg ilaprazole
Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of ilaprazole and one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks
Experimental: 15 mg ilaprazole Drug: 15 mg ilaprazole
Three 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks
Active Comparator: 40 mg esomeprazole Drug: 40 mg esomeprazole
One 40-mg esomeprazole tablet (AstraZeneca, Nexium) together with three 5-mg placebo tablets of ilaprazole in a package being taken orally each morning on an empty stomach for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107938

Contacts
Contact: Haitang Hu, MD +86 13892890474 wl1020_2000@126.com

Sponsors and Collaborators
Livzon Pharmaceutical Group Inc.
Investigators
Principal Investigator: Sanren Lin, MD Peking University Third Hospital
Principal Investigator: Liya Zhou, MD Peking University Third Hospital
  More Information

No publications provided

Responsible Party: Haitang Hu, Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT01107938     History of Changes
Other Study ID Numbers: Livzon-IY-81149R-09, SFDA2004L00137
Study First Received: April 19, 2010
Last Updated: April 20, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Livzon Pharmaceutical Group Inc.:
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013