chronic constipation
Conditions
Interventions
Intervention type:DRUG
Name of intervention:Ganaton,Amitiza Capsules 24 microgram
Dose form / Japanese Medical Device Nomenclature:TABLET,CAPSULE
Route of administration / Site of application:ORAL,ORA
Sponsors
Matsuda Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of nausea events during the 14-day period | — |
Secondary
| Measure | Time frame |
|---|---|
| Nausea-related dropout rate, Nausea severity level, Clinical efficacy of AmitizaR in treating chronic constipation, Drug safety | — |
Countries
Japan
Contacts
Public ContactMitsuyo Yano
Matsuda Hospital, Colo-Proctology
Outcome results
None listed