Clinical trial NCT01107938: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Lead sponsor: Livzon Pharmaceutical Group Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-21
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the proportion of patients with healed esophagitis at week 8
timeFrame: week 8
Secondary outcomes:
measure: the proportion of patients healed at week 4
timeFrame: week 4
measure: resolution of clinical symptoms
timeFrame: week 8
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Sanren Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Liya Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.