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

NCT00953381 | Completed Phase 2 DMC

• 2 other identifiers: Livzon-IY-81149-012004L00137
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Duodenal Ulcer

Keywords

Ilaprazole; Proton pump inhibitor; Duodenal ulcer; Acid suppression; Randomized trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Secondary endpoints included post-treatment resolution of related gastrointestinal symptoms such as upper abdominal pain, heartburn, acid regurgitation, nausea & vomiting, eructation, and increased flatus.

  week 4

Study Arms (4)

5 mg ilaprazole

EXPERIMENTAL

Drug: 5 mg ilaprazole

10 mg ilaprazole

EXPERIMENTAL

Drug: 10 mg ilaprazole

20 mg ilaprazole

EXPERIMENTAL

Drug: 20 mg ilaprazole

20 mg omeprazole

ACTIVE COMPARATOR

Drug: 20 mg omeprazole

Interventions

5 mg ilaprazole DRUG

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

5 mg ilaprazole

10 mg ilaprazole DRUG

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

10 mg ilaprazole

20 mg ilaprazole DRUG

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

20 mg ilaprazole

20 mg omeprazole DRUG

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

Also known as: Losec,AstraZeneca

20 mg omeprazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting patients were eligible for enrollment if they:
• were 18-65 years of age,
• had endoscopically diagnosed active duodenal ulcers within the previous 72 hours,
• the number of ulcers was at least one, but no more than two with the larger diameter 0.3-2.0cm.

You may not qualify if:

• Patients were ineligible if they:
• had cancerous or complex ulcers, Zollinger-Ellison syndrome, esophageal erosion or ulcer, varices of esophagus or fundus of stomach, or pyloric stenosis,
• had a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
• 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,
• were female patients who were breast feeding, pregnant, or intended to become pregnant during the study,
• 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,
• participated in a clinical trial with an investigational drug or device within the past three months,
• had hypersensitivity or idiosyncratic reaction to omeprazole or any other benzimidazole,
• had alcoholic intemperance, drug addiction or any other improper habits.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Wang L, Zhou L, Lin S, Hu H, Xia J. A new PPI, ilaprazole compared with omeprazole in the treatment of duodenal ulcer: a randomized double-blind multicenter trial. J Clin Gastroenterol. 2011 Apr;45(4):322-9. doi: 10.1097/MCG.0b013e3181e88515.

  PMID: 20679904 DERIVED

MeSH Terms

Conditions

Duodenal Ulcer

Interventions

ilaprazole; Omeprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• S R Lin, M.D

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 1, 2009
• First Posted: August 6, 2009
• Study Start: October 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: May 1, 2005
• Last Updated: August 6, 2009

Record last verified: 2009-08

Locations

CN (1)