NCT00953381

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

Efficacy and Safety of Ilaprazole for Acute Duodenal Ulcer: A Randomized,Double-Blind,Omeprazole-Controlled,Multicenter,and Phase2 Trial in China

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Duodenal Ulcer

Interventions

Type	Name	Description
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
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
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
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

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-03-01
• Completion: 2005-05-01
• First posted: 2009-08-06
• Last updated: 2009-08-06

Locations

1 site across 1 country: China