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

Chronic Idiopathic Constipation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989234
• Other study ID #: YKP10811C006
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2013
• Last updated: December 3, 2014
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: SK Life Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• YKP10811

• Placebo

Locations

Country	Name	City	State
United States	HBSA, A Supporting Organization of Pacific Institute for Research and Evaluation	Albuquerque	New Mexico
United States	Digestive & Liver Disease Specialists, A Medical Group, Inc.	Anaheim	California
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Austin Center for Clinical Research	Austin	Texas
United States	MW Clinical Research Center	Beaumont	Texas
United States	Dayton Gastroenterology, Inc.	Beavercreek	Ohio
United States	Alliance Clinical Research	Birmingham	Alabama
United States	River Birch Research Alliance, LLC	Blue Ridge	Georgia
United States	Meridien Research	Bradenton	Florida
United States	NY Scientific	Brooklyn	New York
United States	Clinical Research Advantage, Inc. / Warner Family Practice, PC	Chandler	Arizona
United States	Connect Clinical Research Center	Chandler	Arizona
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	May Medical Center	Chicago	Illinois
United States	Precision Research Institute	Chula Vista	California
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Hilltop Physicians IN / Hightop Medical Research Center	Cincinnati	Ohio
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Alpha Clinical Research, LLC	Clarksville	Tennessee
United States	Clinical Research Advantage, Inc. / Colorado Springs Health Partners, SW	Colorado Springs	Colorado
United States	Columbus Clinical Research Inc.	Columbus	Ohio
United States	PMG Research of Charlotte	Concord	North Carolina
United States	Partners in Clinical Research, LLC	Cumberland	Rhode Island
United States	AGA Clinical Research Associates, LLC	Egg Harbor Township	New Jersey
United States	Triwest Research Associates, LLC	El Cajon	California
United States	Diagnamics Inc.	Encinitas	California
United States	Clinical Research Advantage, Inc.	Evansville	Indiana
United States	Pharmakon Inc.	Evergreen Park	Illinois
United States	Clinical Research Advantage, Inc.	Henderson	Nevada
United States	Palm Springs Research Institute	Hialeah	Florida
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Houston Endoscopy & Research Center	Houston	Texas
United States	Therapeutic Research Institute of Orange County	Laguna Hills	California
United States	AB Clinical Trials	Las Vegas	Nevada
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Clinical Trials Research	Lincoln	California
United States	Applied Research Center Arkansas, Inc.	Little Rock	Arkansas
United States	Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia
United States	Gastrointestinal Specialists of Georgia	Marietta	Georgia
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	Prestige Clinical Research Center Inc.	Miami	Florida
United States	The Clinical Research Institute	Miami	Florida
United States	Physicians Regional Medical Group	Naples	Florida
United States	KAMP Medical Research, Inc.	Natchitoches	Louisiana
United States	Medex Healthcare Research, Inc.	New York	New York
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Alliance Clinical Research	Oceanside	California
United States	Advanced Research Institute	Ogden	Utah
United States	COR Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Advanced Gastroenterology Associates, LLC	Palm Harbor	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC	Phoenix	Arizona
United States	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania
United States	The Oregon Clinic, PC - Gastroenterology West	Portland	Oregon
United States	Health Concepts	Rapid City	South Dakota
United States	Northern California Research	Sacramento	California
United States	Radiant Research Inc.	San Antonio	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	The Research Institute	Springfield	Massachusetts
United States	Sundance Clinical Research, LLC	St. Louis	Missouri
United States	Clinical Research Trials of Florida, Inc.	Tampa	Florida
United States	Clinical Associates Ambulatory Surgical Center	Towson	Maryland
United States	Options Health Research, LLC	Tulsa	Oklahoma
United States	Digestive Health Specialists of Tyler, LLP	Tyler	Texas
United States	Coastal Research Associates, Inc.	Weymouth	Massachusetts
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects with improved bowel movement frequency		12 weeks	No
Secondary	Stool frequency		12 weeks	No
Secondary	Daily average ratings of stool consistency		12 weeks	No
Secondary	Instances of rescue medicine usage		12 weeks	No
Secondary	Onset time to CSBM		12 weeks	No
Secondary	Onset time to SBM		12 weeks	No
Secondary	Severity of straining		12 weeks	No
Secondary	Abdominal discomfort		12 weeks	No
Secondary	Abdominal pain		12 weeks	No
Secondary	Bloating		12 weeks	No
Secondary	Constipation severity		12 weeks	No