chronic constipation
Conditions
Interventions
Treatment is started from 24 microgram 2 times a day of rubiprostone, patients who developed Adverse Event is changed to 12 microgram 2 times per day.
chronic constipation
Sponsors
Ohbayashi Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lubiprostone treatment continuation rate after onset of nausea or vomiting | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of bowel movements per day after the dose change from 24 microgram BID to 12 microgram BID 2.Number of days with bowel movements per week after the dose change from 24 microgram BID to 12 microgram BID 3.Number of bowel movements per day after continued use of 24 microgram BID 4.Number of days with bowel movements per week after continued use of 24 microgram BID 5.Assessment of change from baseline in bristol stool scale 6.Number of both bowel movement per day and days with bowel movements per week in stimulant laxatives use group and non-use group after the dose change from 24 microgram BID to 12 microgram BID 7.Number of both bowel movement per day and days with bowel movements per week in prokinetic agents use group and non-use group 8.Lubiprostone treatment continuation rate after all adverse events | — |
Contacts
Public ContactHiroyuki Ohbayashi
Tohno Chuo Clinic
Outcome results
None listed