- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00816205
An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Zrifin, Israel
- Dept of Gastroeneterology, Asaf Harofe Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
This is an open label, dose-finding study.
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy parameter is change in Resting Anal Pressure from baseline.
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDD102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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