Switch Study

JRCT ID: jRCTs031200168

Registered date:22/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: chronic constipation
• Date of first enrollment: 25/01/2021
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Change stimulant laxative to lubiprostone and treat.

Outcome(s)

• Primary Outcome: Frequency of spontaneous defecation in the first week after administration of lubiprostone

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: < 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Masaki Maruyama
• Secondary Sponsor: Mylan EPD G.K.