chronic constipation chronic constipation
Conditions
Interventions
Change stimulant laxative to lubiprostone and treat.
Sponsors
Masaki Maruyama
Mylan EPD G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diag nosed with chronic constipation 2) Patients who, after receiving a sufficient explanation before participating in this study, can obtain a free written informed consent of themselves 3) Patients who can comply with the compliance requirements during this study, receive medical examinations, tests, and report symptoms as prescribed in this study plan. 4) Patients over the ag e of 65 and under 90 at the time of obtaining consent (reg ardless of g ender) 5) Patients who can stop taking stimulant laxatives during the study drug administration period 6) Patients who continue to take stimulant laxative for at least 2 weeks before study drug administration
Exclusion criteria
Exclusion criteria: 1) Patients with severe cardiopulmonary disorders 2) Patients with confirmed or suspected intestinal obstruction due to tumor, hernia, etc. 3) Patients with a history of hypersensitivity to the components of the drug used 4) Patients who participated in other clinical trials and received study drug within 1 month of the start of this study (calculated from the study drug administration date) 5) Patients taking lubiprostone within 3 months of participating in this study 6) Patients with moderate or severe liver dysfunction 7) Patients with severe renal dysfunction 8) Other patients who are judg ed to be inappropriate by the investig ator or the investig ator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of spontaneous defecation in the first week after administration of lubiprostone | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Number of spontaneous defecations in the 2nd and 4th weeks after administration of lubiprostone 2) Time to the first spontaneous defecation after taking Lubiprostone 3) Chang es in QOL before taking lubiprostone and after 28 days of administration 4) Transition of Bristol scale 5) Chang es in the scores of the following items before taking lubiprostone and after 28 days of administration Abdominal pain, bloating , nausea, vomiting , depressed mood, loss of appetite, stools during defecation, feeling of remaining stool 6) Number of adverse events/side effects and the number of occurrences | — |
Contacts
Public ContactMaruyama Masaki
Kashiwazaki General Hospital and Medical Center
Outcome results
None listed