Switch Study

Not Applicable

• Conditions: chronic constipation

• Registration Number: JPRN-jRCTs031200168
• Lead Sponsor: Masaki Maruyama

Brief Summary

The switch to lubiprostone alone in patients taking continuous stimulant laxatives has no major safety issues, maintaining short-term SBM and bristol scale, but after 4 weeks a trend was seen to be lowering SBM and quality of life.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Study Completion: 2021-09-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 106

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of spontaneous defecation in the first week after administration of lubiprostone

Secondary Outcome Measures

Name	Time	Method
1) Number of spontaneous defecations in the 2nd and 4th weeks after administration of lubiprostone<br>2) Time to the first spontaneous defecation after taking Lubiprostone<br>3) Chang es in QOL before taking lubiprostone and after 28 days of administration<br>4) Transition of Bristol scale<br>5) Chang es in the scores of the following items before taking lubiprostone and after 28 days of administration<br>Abdominal pain, bloating , nausea, vomiting , depressed mood, loss of appetite, stools during defecation, feeling of remaining stool<br>6) Number of adverse events/side effects and the number of occurrences