Status:
COMPLETED
Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
Lead Sponsor:
RDD Pharma Ltd
Conditions:
Incontinence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject suitability for inclusion in the trial. ...
Detailed Description
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject suitability for inclusion in the trial. W...
Eligibility Criteria
Inclusion
- Signed written informed consent.
- Male or female subjects 18 to 55 years of age.
Exclusion
- Active or chronic disease.
- In need of chronic use of medication, with the exception of birth control medications.
- Currently uses medication for acute illness.
- Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin, Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
- Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
- Receipt of any investigational treatment (drug or device) within 90 days prior to screening.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00972998
Start Date
September 1 2009
End Date
December 1 2009
Last Update
December 29 2009
Active Locations (1)
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1
Dept of Gastroeneterology, Asaf Harofe Medical Center
Zrifin, Israel, 70300