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This is a Phase IIa, 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.
This is a Phase IIa, 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. Subjects diagnosed with chronic idiopathic constipation (CIC) will be screened for the anticipated 4 cohorts, to yield 80 randomized subjects for enrollment. Three dose cohorts are planned (1.0 mg, 3.0mg, 9.0 mg and 0.3 mg) with 20 subjects per dose cohort [randomization ratio 3:1 (15 receive SP-304:5 receive placebo)]. Subjects 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 subject will complete all 14 days of dosing (including making accurate BM diary entries for all 14 days in the treatment period). All subjects receiving at least one dose of SP-304 or matching placebo will be considered evaluable for the safety endpoints. If a subject 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, he/she will be considered evaluable.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Chronic Idiopathic Constipation
SP-304, SP-304, SP-304, Placebo, SP-304 0.3 mg
Novara Clinical Research
Synergy Pharmaceuticals, Inc.
Published on BioPortfolio: 2014-08-27T03:16:28-0400
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