Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 2)

This study has been completed.
Sponsor:
Information provided by:
Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier:
NCT00953381
First received: August 1, 2009
Last updated: August 5, 2009
Last verified: August 2009
  Purpose

Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and dose-ranging trial. They were randomly assigned into four groups to be treated for up to four weeks and be seen at week 1, 2 and 4: three of ilaprazole, 5, 10, and 20 mg/day, and one of omeprazole 20 mg/day as positive control. The primary endpoint was the ulcer healing rate at week 4. Healing of ulcer was determined by its resolution from active to scarring stage. Symptoms relief was evaluated as secondary end points by using a graded score. Safety and tolerability were evaluated on basis of clinical assessments.


Condition Intervention Phase
Duodenal Ulcer
Drug: 5 mg ilaprazole
Drug: 10 mg ilaprazole
Drug: 20 mg ilaprazole
Drug: 20 mg omeprazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ilaprazole for Acute Duodenal Ulcer: A Randomized,Double-Blind,Omeprazole-Controlled,Multicenter,and Phase2 Trial in China

Resource links provided by NLM:


Further study details as provided by Livzon Pharmaceutical Group Inc.:

Primary Outcome Measures:
  • The primary endpoint was the healing rate of ulcers, which based on post-treatment (week 4) endoscopic changes in stage of the ulcer relative to baseline (week 0) levels. [ Time Frame: week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as upper abdominal pain, heartburn, acid regurgitation, nausea & vomiting, eructation, and increased flatus. [ Time Frame: week 4 ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: October 2004
Study Completion Date: May 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 mg ilaprazole Drug: 5 mg ilaprazole
One 5-mg ilaprazole tablet (Livzon Pharm Group Inc., China) together with three placebo tablets and one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
Experimental: 10 mg ilaprazole Drug: 10 mg ilaprazole
Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with two placebo tablets and one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
Experimental: 20 mg ilaprazole Drug: 20 mg ilaprazole
Four 5-mg ilaprazole tablets together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
Active Comparator: 20 mg omeprazole Drug: 20 mg omeprazole
One 20-mg omeprazole capsule (AstraZeneca, Losec) together with four placebo tablets in a package being taken orally each morning on an empty stomach for 4 weeks
Other Name: Losec,AstraZeneca

Detailed Description:

The primary endpoint was the healing rate of ulcers, which based on post-treatment (week 4) endoscopic changes in stage of the ulcer relative to baseline (week 0) levels. Stages of the ulcers were endoscopically assessed according to the degree of ulceration, regenerating epithelialization, and scarring, which was defined as follows: A stage (active stage, A1 & A2) where A1 stage is more severe than A2 stage, H stage (healing stage, H1 & H2) where H2 stage is better than H1 stage, and S stage (scarring stage, S1 (red scar) & S2 (white scar)) where S stage is the best stage in the three stages and S2 stage is better than S1.Healing of ulcer is deemed successful if an ulcer in A stage resolved to S stage at the end of the treatment period, regardless of S1 or S2. When endoscopy demonstrated successful ulcer healing, study medication was discontinued. Patients returned at week 2, and if unhealed further endoscopic assessment would be done at week 4. Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as upper abdominal pain, heartburn, acid regurgitation, nausea & vomiting, eructation, and increased flatus. These symptoms were recorded on a scale ranging from 0 to 3(0=none, 1=mild, 2=moderate, 3=severe) at baseline, week 1, 2, and 4. Resolution of symptoms were defined as "excellence", "effective", "improved", or "ineffective" relative to baseline levels, of which complete symptom relief or complete absence of the symptom without recurrence was deemed as "excellence". Safety assessments based mainly on the occurrence, frequency, and severity of adverse events, which were monitored throughout the duration of the study, and also based on comprehensive indexes, including physical examination, electrocardiography, and routine laboratory investigations, which were performed at baseline and repeated at the end of the treatment period. For all adverse events, where necessary, patients were withdrawn from the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consenting patients were eligible for enrollment if they:

    1. were 18-65 years of age,
    2. had endoscopically diagnosed active duodenal ulcers within the previous 72 hours,
    3. the number of ulcers was at least one, but no more than two with the larger diameter 0.3-2.0cm.

Exclusion Criteria:

  • Patients were ineligible if they:

    1. had cancerous or complex ulcers, Zollinger-Ellison syndrome, esophageal erosion or ulcer, varices of esophagus or fundus of stomach, or pyloric stenosis,
    2. had a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
    3. had severe complications (e.g., pyloric obstruction, active bleeding under endoscope), severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
    4. were female patients who were breast feeding, pregnant, or intended to become pregnant during the study,
    5. had 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,
    6. participated in a clinical trial with an investigational drug or device within the past three months,
    7. had hypersensitivity or idiosyncratic reaction to omeprazole or any other benzimidazole,
    8. had alcoholic intemperance, drug addiction or any other improper habits.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953381

Locations
China, Beijing
Peking University Third Hospital
Beijing, Beijing, China
Sponsors and Collaborators
Livzon Pharmaceutical Group Inc.
Investigators
Principal Investigator: S R Lin, M.D Peking University Third Hospital
  More Information

No publications provided by Livzon Pharmaceutical Group Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Haitang Hu, Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT00953381     History of Changes
Other Study ID Numbers: Livzon-IY-81149-01, 2004L00137
Study First Received: August 1, 2009
Last Updated: August 5, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Livzon Pharmaceutical Group Inc.:
Ilaprazole
Proton pump inhibitor
Duodenal ulcer
Acid suppression
Randomized trial

Additional relevant MeSH terms:
Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014