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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Efficacy and Safety of Ilaprazole for GERD: A Randomized,Double-Blind, Esomeprazole-Controlled,Phase2,Multicenter Trial in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01107938
• Other study ID #: Livzon-IY-81149R-09
• Secondary ID: SFDA2004L00137
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 19, 2010
• Last updated: April 20, 2010
• Start date: May 2010

Study information

• Verified date: April 2010
• Source: Livzon Pharmaceutical Group Inc.
• Contact: Haitang Hu, MD
• Phone: +86 13892890474
• Email: wl1020_2000[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Livzon Pharmaceutical Group Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients with healed esophagitis at week 8		week 8	No
Secondary	the proportion of patients healed at week 4		week 4	No
Secondary	resolution of clinical symptoms		week 8	No