Ilaprazole for the Treatment of Duodenal Ulcer in Chinese Patients (Phase 3)

Duodenal Ulcer Clinical Trial

Official title:

Efficacy and Safety of Ilaprazole for Acute Duodenal Ulcer: A Randomized,Double-Blind,Omeprazole-Controlled,Multicenter,and Phase3 Trial in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952978
• Other study ID #: Livzon-IY-81149-03
• Secondary ID: 2005L02943
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2009
• Last updated: August 5, 2009
• Start date: September 2005
• Est. completion date: May 2006

Study information

• Verified date: August 2009
• Source: Livzon Pharmaceutical Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Patients with endoscopically diagnosed active duodenal ulcer disease were enrolled in a randomized, double-blind, parallel and positive-controlled trial. They were randomly assigned into two groups, 10 mg/day ilaprazole and 20 mg/day omeprazole, to be treated for up to four weeks and be seen at week 1, 2 and 4. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: May 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 and

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.

Study Design

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

Related Conditions & MeSH terms

• Duodenal Ulcer
• Ulcer

Intervention

Drug:
• 10 mg ilaprazole
Two 5-mg ilaprazole tablets(Livzon Pharm Group Inc., China) together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
• 20 mg omeprazole
One 20-mg omeprazole capsule (AstraZeneca, Losec) together with two placebo tablets in a package being taken orally each morning on an empty stomach for 4 weeks

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Livzon Pharmaceutical Group Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		week 4	No
Secondary	Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as nightly pain, heartburn, nightly acid regurgitation, nausea & vomiting, eructation, and increased flatus.		week 4	No