Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02729909
Status:
COMPLETED
Last Update Posted:
2019-04-01
First Post:
2016-04-01
Brief Title:
Lubiprostone for Chronic Idiopathic Constipation Treatment
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blind Parallel-Group Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lubiprostone for the Treatment of Chronic Idiopathic Constipation
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of oral administration of 24 ug of lubiprostone twice daily BID for 4 weeks in participants with chronic idiopathic constipation CIC compared with placebo
Detailed Description:
The drug being tested in this study is called lubiprostone Lubiprostone is being tested to treat people who have chronic idiopathic constipation This study will look at the frequency of spontaneous bowel movements SBMs in people who take lubiprostone compared to placebo
The study will enroll approximately 211 participants Participants will be randomly assigned by chance like flipping a coin equally to one of the two treatment groups which will remain undisclosed to the participant and study doctor during the study unless there is an urgent medical need
Lubiprostone 24 μg
Placebo dummy inactive pill - this is a capsule that looks like the study drug but has no active ingredient
All participants will be asked to take one capsule with breakfast and one capsule with dinner each day throughout the study All participants will be asked to record each time they have a SBM and all details of each SBM including the consistency of the stool and the difficulty they have in passing it in a diary
This multi-center trial will be conducted in Mexico The overall time to participate in this study is 8 weeks Participants will make multiple visits to the clinic and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment
The study will enroll approximately 211 participants Participants will be randomly assigned by chance like flipping a coin equally to one of the two treatment groups which will remain undisclosed to the participant and study doctor during the study unless there is an urgent medical need
Lubiprostone 24 μg
Placebo dummy inactive pill - this is a capsule that looks like the study drug but has no active ingredient
All participants will be asked to take one capsule with breakfast and one capsule with dinner each day throughout the study All participants will be asked to record each time they have a SBM and all details of each SBM including the consistency of the stool and the difficulty they have in passing it in a diary
This multi-center trial will be conducted in Mexico The overall time to participate in this study is 8 weeks Participants will make multiple visits to the clinic and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 153300410A0196 | REGISTRY | RNEC | None |
| U1111-1168-6358 | REGISTRY | None | None |