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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01989234
Other study ID # YKP10811C006
Secondary ID
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


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
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