PMID- 20679904 OWN - NLM STAT- MEDLINE DCOM- 20110713 LR - 20131121 IS - 1539-2031 (Electronic) IS - 0192-0790 (Linking) VI - 45 IP - 4 DP - 2011 Apr TI - A new PPI, ilaprazole compared with omeprazole in the treatment of duodenal ulcer: a randomized double-blind multicenter trial. PG - 322-9 LID - 10.1097/MCG.0b013e3181e88515 [doi] AB - GOALS: To investigate the efficacy and safety of a new proton pump inhibitor (PPI), ilaprazole (IY-81149) in the treatment of duodenal ulcers and provide some characteristics of the dose-response relationship for later studies. BACKGROUND: PPIs have been used therapeutically for many years, and shown great efficacy in accelerating ulcer healing. Currently researches are focused on more potent PPIs. Some preclinical studies have shown that ilaprazole might be such a new substitute. STUDY: 235 patients with at least 1 endoscopically diagnosed active duodenal ulcer were enrolled in a randomized trial. Patients were randomized into 4 groups (5, 10, and 20 mg/d ilaprazole, with 20 mg/d omeprazole as positive control) and treated for up to 4 weeks. Forty patients accepted continuous 24-hour pH measurements after the fifth dose. The primary endpoint was ulcer healing rate at week 4. RESULTS: The efficacy analyses were based on 235 patients. At week 4, 86.4%, 93.1%, 86.4%, and 89.8% patients treated with 5 mg ilaprazole, 10 mg ilaprazole, 20 mg ilaprazole, and 20 mg omeprazole once daily, respectively had ulcers healed (P=0.59). The majority of patients (>70%) became asymptomatic after 4 weeks treatment. Both drugs with stipulated dosages exhibited similar efficacy and safety profiles. Gastric acid suppression increased with increasing dose of ilaprazole in pH study. CONCLUSIONS: Ilaprazole is as tolerable, safe, and efficacious as omeprazole in the treatment of duodenal ulcers, especially at a lower dose (10 mg/d ilaprazole vs. 20 mg/d omeprazole). (ClinicalTrials.gov ID: NCT00953381). FAU - Wang, Ling AU - Wang L AD - Department of Health Statistics, The Fourth Military Medical University, Xi'an, Shaanxi, China. FAU - Zhou, Liya AU - Zhou L FAU - Lin, Sanren AU - Lin S FAU - Hu, Haitang AU - Hu H FAU - Xia, Jielai AU - Xia J LA - eng SI - ClinicalTrials.gov/NCT00953381 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Clin Gastroenterol JT - Journal of clinical gastroenterology JID - 7910017 RN - 0 (2-Pyridinylmethylsulfinylbenzimidazoles) RN - 0 (Anti-Ulcer Agents) RN - 0 (Benzimidazoles) RN - 0 (Proton Pump Inhibitors) RN - 0 (Sulfoxides) RN - 776Q6XX45J (ilaprazole) RN - KG60484QX9 (Omeprazole) SB - IM MH - 2-Pyridinylmethylsulfinylbenzimidazoles MH - Adult MH - Anti-Ulcer Agents/administration & dosage/adverse effects/*therapeutic use MH - Benzimidazoles/administration & dosage/adverse effects/*therapeutic use MH - Double-Blind Method MH - Duodenal Ulcer/*drug therapy MH - Female MH - Humans MH - Male MH - Middle Aged MH - Omeprazole/administration & dosage/adverse effects/*therapeutic use MH - *Proton Pump Inhibitors/administration & dosage/adverse effects/*therapeutic use MH - Sulfoxides/administration & dosage/adverse effects/*therapeutic use MH - Treatment Outcome EDAT- 2010/08/04 06:00 MHDA- 2011/07/14 06:00 CRDT- 2010/08/04 06:00 PHST- 2010/08/04 06:00 [entrez] PHST- 2010/08/04 06:00 [pubmed] PHST- 2011/07/14 06:00 [medline] AID - 10.1097/MCG.0b013e3181e88515 [doi] PST - ppublish SO - J Clin Gastroenterol. 2011 Apr;45(4):322-9. doi: 10.1097/MCG.0b013e3181e88515.