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SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation

NCT01053962 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-01-02

Study results available
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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.

Conditions

  • Chronic Idiopathic Constipation

Interventions

DRUG

SP-304 0.3 mg

SP-304 0.3 mg

DRUG

SP-304 1.0 mg

SP-304 1.0 mg

DRUG

SP-304 3.0 mg

SP-304 3.0 mg

DRUG

SP-304 9.0 mg

SP-304 9.0 mg

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Gary S Jacob, Ph.D. · Synergy Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053962 on ClinicalTrials.gov