CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
SP-304 0.3 mg +4 moredrug
Likely dose
SP-304 0.3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01053962
NCT01053962Phase 2Completed
CompareCT.gov

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

Bausch Health Americas, Inc.·interventional·Posted Jan 22, 2010·Updated Jan 2, 2020

In Brief

A Phase 2 clinical trial evaluating SP-304 0.3 mg, SP-304 1.0 mg, and 3 other interventions for Chronic Idiopathic Constipation. Completed, enrolled 84 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Constipation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 22, 2010
Enrollment StartMar 1, 2010
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.4 years ago

Interventions

SP-304 0.3 mgdrug

SP-304 0.3 mg

SP-304 1.0 mgdrug

SP-304 1.0 mg

SP-304 3.0 mgdrug

SP-304 3.0 mg

SP-304 9.0 mgdrug

SP-304 9.0 mg

Placebodrug

Placebo