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

NCT ID: NCT01107938

Last Updated: 2010-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

10 mg ilaprazole

Group Type: EXPERIMENTAL

10 mg ilaprazole

Intervention Type: DRUG

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

Group Type: EXPERIMENTAL

15 mg ilaprazole

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

40 mg esomeprazole

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Livzon Pharmaceutical Group Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Livzon Pharmaceutical Group Inc.

Principal Investigators

Sanren Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Liya Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Central Contacts

Haitang Hu, MD

Role: CONTACT

wl1020_2000@126.com

+86 13892890474

References

Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A Randomized, Double-blind, Active-Controlled, Multi-center Study of Ilaprazole in the Treatment of Reflux Esophagitis. Clin Drug Investig. 2016 Dec;36(12):985-992. doi: 10.1007/s40261-016-0446-3.

Reference Type: DERIVED

PMID: 27605258 (View on PubMed)

Other Identifiers

SFDA2004L00137

Identifier Type: -

Identifier Source: secondary_id

Livzon-IY-81149R-09

Identifier Type: -

Identifier Source: org_study_id