Status:
COMPLETED
An Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects
Lead Sponsor:
RDD Pharma Ltd
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be participating in this study. This study is composed of 2 parts: Part 1 is a dose finding study. Part 2 is a pharma...
Eligibility Criteria
Inclusion
- Signed written informed consent.
- Male or female subjects 18 to 55 years of age;
Exclusion
- Known allergy to the active drug or excipients.
- Pregnancy or lactation.
- Active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
- Type 1 diabetes mellitus;
- Insulin treated type 2 diabetes mellitus;
- Renal insufficiency.
- Liver insufficiency.
- Malignant disease within 5 years of screening;
- History of rectal surgery.
- History of HIV, hepatitis B, hepatitis C.
- Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
- Chronic use of medications with the exception of birth control pills.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01265485
Start Date
August 1 2011
End Date
August 1 2011
Last Update
August 23 2011
Active Locations (1)
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1
Gastroeneterology dept, Asaf harofe Medical center
Zrifin, Israel