Status:
COMPLETED
A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Chronic Constipation
Functional Constipation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
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 me...
Eligibility Criteria
Inclusion
- Non-smokers (refrained from any tobacco or nicotine usage, including smokeless tobacco, nicotine patches, etc.) for at least 6 months prior to Day 1 of the study
- Body Mass Index of 19 through 40 kg/m2
- Participants must be willing to follow dietary restrictions
- Females of childbearing potential (ie, not menopausal, no hysterectomy, no bilateral oophorectomy) must complete a negative pregnancy test (urine) prior to receiving any radioisotopes
- No evidence of pelvic floor dysfunction
- If clinically indicated, absence of an evacuation disorder should be confirmed within 30 days prior to the first dose of study medication
- At Screening, patients must meet ROME III Criteria for FC, which assumes an absence of a structural or biochemical explanation
- The patient's screening (baseline) colonic transit test must show a GC ≤ 2.4 at 24 hours; and
- Baseline EKG shows QTc interval ≤ 450mSec
Exclusion
- History of clinically-significant manifestations or current abnormality of any organ system
- History of inflammatory bowel disease
- Any history of GI surgery within 6 months prior to the first dose of study medication
- History of clinically-significant prolonged diarrhea, in the absence of a laxative
- Patients who have started a special dietary habit and/or an intense physical workout program within 4 weeks prior to the first dose of study medication
- Any clinically-significant surgical procedure within 30 days prior to the first dose of study medication
- History of alcoholism or drug addiction within 12 months prior to the first dose of study medication
- Any patient who has had an acute illness within 5 days prior to the first dose of study medication, eg, flu syndrome, GI virus, indigestion
- Patients who are breastfeeding
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01523184
Start Date
March 1 2012
End Date
November 1 2013
Last Update
July 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905