A Clinical Study to Evaluate the Usefulness of Concomitant Itopride Hydrochloride (Ganaton) for the Treatment of Nausea Associated with Lubiprostone (Amitiza) - MTD-LUBI
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
In patients with chronic constipation, the onset of nausea and vomiting and the percentage of patients forced to discontinue treatment were compared between patients treated with lubiprostone alone and patients treated with a combination of lubiprostone and itopride. There was no confirmed significant difference between the two groups in terms of biostatistical parameters, but concomitant use of itopride was suggested to be useful in suppressing the severity of nausea and promoting usefulness of continued use of lubiprostone. Because the efficacy of lubiprostone during the study period was confirmed, it seems possible to suppress discontinuation of lubiprostone treatment due to these events if the dose level is adjusted appropriately on the basis of the mechanism of action and pharmacokinetics of the concomitantly used gastrointestinal motility activator.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. Patient diagnosed with chronic constipation.
- •2. Male or female outpatient between 20 and 75 years of age at the time consent is given
- •3. Patient who has never been on AMITIZA
- •4. Patient agreed to achieve satisfactory compliance to the regimen of medication stipulated in written form, and to undergo all medical examinations, report symptoms to the investigator, and keep the patient's diary through study inclusion period, as per required in study protocol.
排除标准
- •1. Patient found or suspected with mechanical intestinal obstruction i.e. intestinal obstruction by tumor, hernia, etc.
- •2. Patients with history of hypersensitivity to any ingredients of AMITIZA.
- •3. Patients with history of hypersensitivity to any ingredients of GANATON.
- •4. Patient either with serious cardiovascular disease, pneumonic disease, hepatic disease, kidney disease, gastrointestinal disease, neuropathic disorder, psychiatric disorder including alcohol or drug abuse, or any type of systemic disease.
- •5. Patient either in pregnancy, in lactation, planning to conceive during study period, or possibly in pregnancy due to inadequate contraception.
- •6. Patient who has taken itopride hydrochloride or mosapride citrate hydrate within three days before study start date i.e. the start date of study drug.(date is calculated from the start date of the study).
- •7. Patient who has been on any clinical trial or on any exploratory therapy within one month before study start date i.e. the start date of study drug. (date is calculated from the start date of the study).
- •8. Patient deemed inappropriate by investigators and researchers regardless of the reason.