NCT01523184

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

A Phase II, Single-Center, Randomized, Parallel Group, Multiple Administration, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

If the participant fulfills the initial eligibility criteria, the patient will be randomized to 1 of the active treatment groups or placebo. During the treatment period, patients will receive study medication once daily for 8 days. Patients will undergo scintigraphic assessment of gastric, small bowel and colonic transit of solids over the 48-hour period. Patients will be males or females, 18 through 65 years of age with a body mass index (BMI) of 19 through 40 kg/m2, with Chronic Constipation or Functional Constipation and no evidence of evacuation disorder as assessed by the Investigator and meet all the inclusion criteria and none of the exclusion criteria.

Conditions

• Chronic Constipation
• Functional Constipation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-02-01
• Last updated: 2014-07-04

Locations

1 site across 1 country: United States