A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation

NCT01989234 | Completed Phase 2 DMC

• 1 other identifier: YKP10811C006
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 69

Brief Summary

This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811 capsules in patients with chronic idiopathic constipation. Following a 2-week baseline period, approximately 320 eligible patients with \<3 complete spontaneous bowel movements (CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by a 2 week follow-up period. The objectives of this study are:

• To assess the efficacy of YKP10811 once daily at relieving constipation and associated symptoms in subjects with chronic idiopathic constipation.
• To determine the safety and tolerability of YKP10811 once daily in subjects with chronic idiopathic constipation.

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with improved bowel movement frequency

  12 weeks

Secondary Outcomes (10)

• Stool frequency

  12 weeks

• Daily average ratings of stool consistency

  12 weeks

• Instances of rescue medicine usage

  12 weeks

• Onset time to CSBM

  12 weeks

• Onset time to SBM

  12 weeks

Study Arms (4)

Placebo Comparator

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo

YKP10811 High Dose

EXPERIMENTAL

YKP10811 High Dose

Drug: YKP10811

YKP10811 Mid Dose

EXPERIMENTAL

YKP10811 Mid Dose

Drug: YKP10811

YKP10811 Low Dose

EXPERIMENTAL

YKP10811 Low Dose

Drug: YKP10811

Interventions

YKP10811 DRUG

YKP10811 High Dose; YKP10811 Low Dose; YKP10811 Mid Dose

Placebo DRUG

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet modified Rome II criteria for Chronic Constipation.
• Patients who are male or female, 18 to 65 years of age inclusive.
• At Visit 3, patients must have \< 3 CSBMs per week and ≤ 5 SBMs per week during the 2-week baseline period.

You may not qualify if:

• Patients who meet Rome II criteria for Irritable Bowel Syndrome (IBS-C).
• Patients with constipation that is drug-induced, or secondary to endocrine, metabolic or, surgery.
• Patients with a clinically significant diseases that would limit the patient's ability to complete and/or participate in the study, including gastrointestinal disorder or surgery, an endocrine abnormality (e.g., diabetes), impaired renal function (GFR of \< 55mL/minute/1.73m2), uncontrolled pulmonary diseases (including asthma), uncontrolled cardiovascular disease (a history of myocardial infarction or cerebrovascular accident within 6 months prior to screening) or significant neurological diseases.
• Patients with a history of inflammatory bowel disease.
• Patients with a history of cancer (other than basal cell or squamous cell carcinoma of the skin completely excised) unless the malignancy has been in complete remission for at least 5 years prior to screening.
• Patients who started a special diet and/or an intense physical workout program within 30 days prior to the beginning of the baseline period or who are intending to substantially modify their dietary habits at any time during the study (patients on a stable, continuous regimen of fiber therapy for at least 30 days prior to the pretreatment baseline period are allowed to continue that therapy, provided that they continue at a constant dose throughout the study.
• Patients with a history of clinically significant hypersensitivity or allergy (facial swelling, hives, breathing difficulty, Stevens-Johnson syndrome etc), in response to any medication, either prescription or nonprescription including an investigational drug, dietary supplement, or herbal medicine.

Sponsors & Collaborators

• SK Life Science, Inc.: lead

Study Sites (69)

Alliance Clinical Research

Birmingham, Alabama, 35213, United States

Location

Clinical Research Advantage, Inc. / Warner Family Practice, PC

Chandler, Arizona, 85224, United States

Location

Connect Clinical Research Center

Chandler, Arizona, 85224, United States

Location

Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, 85020, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Applied Research Center Arkansas, Inc.

Little Rock, Arkansas, 72212, United States

Location

Digestive & Liver Disease Specialists, A Medical Group, Inc.

Anaheim, California, 92801, United States

Location

Precision Research Institute

Chula Vista, California, 91910, United States

Location

Triwest Research Associates, LLC

El Cajon, California, 92020, United States

Location

Diagnamics Inc.

Encinitas, California, 92024, United States

Location

Therapeutic Research Institute of Orange County

Laguna Hills, California, 92653, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

Alliance Clinical Research

Oceanside, California, 92056, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW

Colorado Springs, Colorado, 80906, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

Palm Springs Research Institute

Hialeah, Florida, 33012, United States

Location

The Clinical Research Institute

Miami, Florida, 33125, United States

Location

Prestige Clinical Research Center Inc.

Miami, Florida, 33133, United States

Location

Physicians Regional Medical Group

Naples, Florida, 34119, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States

Location

Clinical Research Trials of Florida, Inc.

Tampa, Florida, 33607, United States

Location

River Birch Research Alliance, LLC

Blue Ridge, Georgia, 30513, United States

Location

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201, United States

Location

Gastrointestinal Specialists of Georgia

Marietta, Georgia, 30060, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

May Medical Center

Chicago, Illinois, 60624, United States

Location

Pharmakon Inc.

Evergreen Park, Illinois, 60805, United States

Location

Clinical Research Advantage, Inc.

Evansville, Indiana, 47714, United States

Location

KAMP Medical Research, Inc.

Natchitoches, Louisiana, 71457, United States

Location

Clinical Associates Ambulatory Surgical Center

Towson, Maryland, 21286, United States

Location

The Research Institute

Springfield, Massachusetts, 01105, United States

Location

Coastal Research Associates, Inc.

Weymouth, Massachusetts, 02190, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Clinical Research Advantage, Inc.

Henderson, Nevada, 89052, United States

Location

AB Clinical Trials

Las Vegas, Nevada, 89119, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89130, United States

Location

Unknown Facility

Las Vegas, Nevada, 89144, United States

Location

AGA Clinical Research Associates, LLC

Egg Harbor, New Jersey, 08234, United States

Location

HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation

Albuquerque, New Mexico, 87102, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Medex Healthcare Research, Inc.

New York, New York, 10016, United States

Location

PMG Research of Charlotte

Charlotte, North Carolina, 28209, United States

Location

PMG Research of Charlotte

Concord, North Carolina, 28025, United States

Location

PMG Research of Hickory, LLC

Hickory, North Carolina, 28605, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Dayton Gastroenterology, Inc.

Beavercreek, Ohio, 45440, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Hilltop Physicians IN / Hightop Medical Research Center

Cincinnati, Ohio, 45224, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Columbus Clinical Research Inc.

Columbus, Ohio, 43213, United States

Location

COR Clinical Research, LLC

Oklahoma City, Oklahoma, 73103, United States

Location

Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

Sunstone Medical Research, LLC

Medford, Oregon, 97504, United States

Location

The Oregon Clinic, PC - Gastroenterology West

Portland, Oregon, 97225, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

Partners in Clinical Research, LLC

Cumberland, Rhode Island, 02864, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Alpha Clinical Research, LLC

Clarksville, Tennessee, 37043, United States

Location

Austin Center for Clinical Research

Austin, Texas, 78756, United States

Location

MW Clinical Research Center

Beaumont, Texas, 77702, United States

Location

Houston Endoscopy & Research Center

Houston, Texas, 77079, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Radiant Research Inc.

San Antonio, Texas, 78229, United States

Location

Digestive Health Specialists of Tyler, LLP

Tyler, Texas, 75701, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

Location

Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Interventions

carbamic acid 3-(4-((4-amino-5-chloro-2-methoxybenzoylamino)methyl)piperidin-1-yl)-1-(4-fluorophenyl)propyl ester

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (69)