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

Livzon Pharmaceutical Group

Status and phase: Unknown; Phase 2

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: 40 mg esomeprazole; Drug: 15 mg ilaprazole; Drug: 10 mg ilaprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107938

Livzon-IY-81149R-09

SFDA2004L00137

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 3 patient groups

10 mg ilaprazole

Experimental group

Treatment:

Drug: 10 mg ilaprazole

15 mg ilaprazole

Experimental group

Treatment:

Drug: 15 mg ilaprazole

40 mg esomeprazole

Active Comparator group

Treatment:

Drug: 40 mg esomeprazole