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



Status:Recruiting
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:5/5/2014
Start Date:October 2013
Contact:Lin-Ming Shen, PhD
Email:lin-ming@sk.com
Phone:201-421-3811

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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.


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.
We found this trial at
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Las Vegas, Nevada 89104
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99 N. Brice Rd
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Macon, Georgia 31201
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1500 E Medical Center Dr
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2713 West Virginia Avenue
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