A study to determine the treatment continuation rate after a dose change to 12microgram BID of lubiprostone in patients with onset of nausea or vomiting at 24microgram BID of lubiprostone

Ohbayashi Hiroyuki0 个研究点目标入组 150 人开始时间: 2018年12月28日最近更新: 2023年10月17日

适应症

试验速览

The continued rate of taking lubiprostone after nausea and vomiting was 81.5%.(n=27,FAS)

•In order to be eligible for participation in this study, the patient must:
•1.be given adequate explanation about the study, fully understand it, and voluntarily agree to participate by giving written informed consent.
•2.be able and willing to follow instructions, make protocol-defined visits, undertake protocol-defined assessments, and report his/her symptoms.
•3.be 20 years and over under 80 years of age at the point of informed consent.
•4.stop taking other medication for treatment of constipation during research drug administration
•5.be diagnosed as chronic constipation

•The patient must be excluded from participating in the study if the patient:
•1.is complicated by a severe cardiopulmonary disorder.
•2.has any condition in which one or both of the study drugs (lubiprostone) is contraindicated according to the contraindications listed in the drugs' package inserts, or has past history of hypersensitivity to any components of the drugs.
•3.participated in other clinical trial and received other investigational drugs within one month prior to the start (first dose) of study treatment of this study.
•4.took lubiprostone within 3 months of participation in this study
•5.is lactating or potentially pregnant.
•6.is unable to use effective contraception methods during the study treatment period.
•7.is considered to be inappropriate to participate in the study for any other reason by the PI/subinvestigator.

发起方

Ohbayashi Hiroyuki