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

Primary Purpose

Gastroesophageal Reflux Disease

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

10 mg ilaprazole

15 mg ilaprazole

40 mg esomeprazole

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

10 mg ilaprazole

15 mg ilaprazole

40 mg esomeprazole

Arm Description

Outcomes

Primary Outcome Measures

the proportion of patients with healed esophagitis at week 8

Secondary Outcome Measures

the proportion of patients healed at week 4

resolution of clinical symptoms

Full Information

NCT ID

NCT01107938

First Posted

April 19, 2010

Last Updated

April 20, 2010

Sponsor

Livzon Pharmaceutical Group Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01107938

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Livzon Pharmaceutical Group Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease

Keywords

GERD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

10 mg ilaprazole

Arm Type

Experimental

Arm Title

15 mg ilaprazole

Arm Type

Experimental

Arm Title

40 mg esomeprazole

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

10 mg ilaprazole

Intervention Description

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

Intervention Name(s)

15 mg ilaprazole

Intervention Description

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

Intervention Name(s)

40 mg esomeprazole

Intervention Description

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

Primary Outcome Measure Information:

Title

the proportion of patients with healed esophagitis at week 8

Time Frame

week 8

Secondary Outcome Measure Information:

Title

the proportion of patients healed at week 4

Time Frame

week 4

Title

resolution of clinical symptoms

Time Frame

week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haitang Hu, MD

Phone

+86 13892890474

wl1020_2000@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanren Lin, MD

Organizational Affiliation

Peking University Third Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Liya Zhou, MD

Organizational Affiliation

Peking University Third Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

27605258

Citation

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.

Results Reference

derived

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

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