MedTrace Logo

A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation

NCT01523184 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2014-07-04

No results posted yet for this study

Summary

This will be a single-center, randomized, parallel group, multiple dose administration, double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation. Four groups including a placebo group will be enrolled and will receive multiple oral doses of YKP10811 or matching placebo.

Conditions

  • Chronic Constipation
  • Functional Constipation

Interventions

DRUG

Placebo Capsule

This is the placebo capsule

DRUG

YKP10811 Drug Product Capsule

The drug product, YKP10811, 10 mg under investigation

DRUG

YKP10811 Drug Product Capsule

The drug product, YKP10811, 20 mg under investigation

DRUG

YKP10811 Drug Product Capsule

The drug product, YKP10811, 30 mg under investigation

Sponsors & Collaborators

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Camilleri, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01523184 on ClinicalTrials.gov