An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects
Information source: RDD Pharma Ltd
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anal Resting Pressure
Intervention: Coated Nifedipine Suppositories (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: RDD Pharma Ltd Overall contact:
Rita Zakorko, Phone: 057-7346233
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 and none
of the exclusion criteria will enter a one day treatment period. During this period, 4 anal
manometric studies will take place. Study medication (Coated Nifedipine suppositories at
various doses) will be administered at pre-determined intervals. During the study, blood
samples will be obtained for plasma Nifedipine analysis.
Clinical Details
Official title: An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects
Study design: Single Group Assignment
Primary outcome: The primary efficacy parameter is change in Resting Anal Pressure from baseline.
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. 90 minutes after each coated suppository insertion this suppository
will be removed and a amnometric study will be performed:
The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed
afterwards will be used to determine baseline anal pressures.
The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of
Nifedipine. The primary efficacy parameter is change in Resting Anal Pressure from
baseline.
The secondary efficacy parameters include the following:
- The ratio of change in anal pressure to plasma Nifedipine level.
- The ratio of change in anal pressure to change in blood pressure.
- The ratio of change in anal pressure to change in heart rate.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
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 Criteria:
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;
Locations and Contacts
Rita Zakorko, Phone: 057-7346233
Dept of Gastroeneterology, Asaf Harofe Medical Center, Zrifin, Israel; Recruiting
Additional Information
Last updated: January 14, 2009
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