Ignite Creation Date:
2024-05-05 @ 10:11 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01053962
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2010-01-12
Brief Title:
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled 14-Day Repeat Oral Dose Ranging Study to Assess the Safety Pharmacokinetic and Pharmacodynamic Effects of SP-304 in Patients With Chronic Idiopathic Constipation
Status:
COMPLETED
Status Verified Date:
2019-12
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:
CIC
Brief Summary:
This is a Phase 2a randomized double-blind placebo-controlled 14-day repeat oral dose ranging study to determine the safety pharmacokinetics PK and pharmacodynamics PD effects of SP-304 in patients with chronic idiopathic constipation
Detailed Description:
This is a Phase 2a randomized double-blind placebo-controlled 14-day repeat oral dose ranging study to determine the safety PK and PD effects of SP-304 in patients with chronic idiopathic constipation Patients diagnosed with chronic idiopathic constipation CIC will be screened for the anticipated 4 cohorts to yield 80 randomized patients for enrollment Four dose cohorts are planned 03 mg 10 mg 30mg and 90 mg with 20 patients per dose cohort randomization ratio 31 15 receive SP-3045 receive placebo Patients who continue to meet all the entry criteria and complete the pre-treatment bowel movement BM diary will receive in a double-blind randomized fashion SP-304 or matching placebo It is expected that each patient will complete all 14 days of dosing including making accurate BM diary entries for all 14 days in the treatment period All patients receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints If a patient receives at least 5 doses per treatment week 1 dose per day for 7 days and has completed BM diary entries for those 5 dosing days in each corresponding treatment week heshe will be considered evaluable
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