drugset / Trial / NCT01053962
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2010-03
- Primary completion
- 2010-08
- Completion
- 2010-08
Publications
- Results Shailubhai K, Talluto C, Comiskey S, Foss J, Joslyn A, Jacob G. Phase II Clinical Evaluation of SP-304, a Guanylate Cyclase-C Agonist, for Treatment of Chronic Constipation. Am J Gastroenterology 105 (Supp 1): S487, 2010
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SP-304 | Unknown | 0.3 mg | Oral |
| Subject | SP-304 | Unknown | 1 mg | Oral |
| Subject | SP-304 | Unknown | 3 mg | Oral |
| Subject | SP-304 | Unknown | 9 mg | Oral |