Ignite Creation Date:
2024-05-05 @ 11:49 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01429987
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2011-09-06
Brief Title:
The Plecanatide Chronic Idiopathic Constipation CIC Study
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
Study SP304-20210 A Randomized 12-Week Double-Blind Placebo-Controlled Repeat-Dose Oral Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation
Status:
COMPLETED
Status Verified Date:
2019-05
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:
This is a randomized double-blind placebo controlled 12 week repeat oral dose dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation CIC
Detailed Description:
This is a Phase IIbIII randomized double-blind placebo-controlled 12-Week Repeat Oral Dose Ranging study to determine the safety and efficacy of plecanatide in patients with chronic idiopathic constipation CIC Subjects diagnosed with CIC via modified Rome III criteria will be screened against the inclusion and exclusion criteria for the study and enter a 2 Week pre treatment screening During this phase patients will be required to call in their bowel movements BM diary as they occur and call at least once daily to complete a patient diary of questions on their symptoms Symptom Diary associated with CC as they will throughout the trial Patients who complete at least 5 days of dosing per week 6 of each 7 day period of BM diary calls and continue to have less than 3 complete spontaneous movements per week as well as meeting other inclusion and exclusion criteria will be enrolled and randomized to one of three plecanatide doses 03 mg 10 mg and 30 mg or placebo 880 patients will be randomized with the intent of having 200 patients per treatment group each group the same size included in efficacy analyses All subjects receiving at least one dose of plecanatide or matching placebo will be included in the safety analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| SP-SP30420210 | None | None | None |