Status:
COMPLETED
An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects
Lead Sponsor:
RDD Pharma Ltd
Conditions:
Anal Resting Pressure
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. Within one week after the screening visit, subjects who meet all inclusion criteria an...
Detailed Description
After detrminig baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 3 Coated Suppositories per study...
Eligibility Criteria
Inclusion
- Subjects meeting the following criteria will be eligible to participate in the trial:
- Signed written informed consent;
- Male or female subjects 18 to 55 years of age;
Exclusion
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Has a clinically significant history or presence of any of the following conditions:
- Known allergy to Nifedipine, polyethylene-glycol, Propylene-glycol or silicone.
- Active or past history of disease that requires medication or clinical follow up.
- Malignant disease within 5 years of screening;
- History of ano rectal disease.
- History of gastrointestinal disease.
- History of gastrointestinal bleeding.
- History of rectal surgery.
- History of gastrointestinal surgery.
- History of HIV.
- In need of chronic use of medication, with the exception of birth control medications.
- Currently uses medication for acute illness.
- Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
- Has received any investigational drug within 90 days of screening;
- Receipt of any investigational treatment (drug or device) within 90 days prior to screening;
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00816205
End Date
April 1 2009
Last Update
April 7 2009
Active Locations (1)
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1
Dept of Gastroeneterology, Asaf Harofe Medical Center
Zrifin, Israel