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| Sponsor: | RDD Pharma Ltd |
|---|---|
| Information provided by: | RDD Pharma Ltd |
| ClinicalTrials.gov Identifier: | NCT00816205 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anal Resting Pressure |
Drug: Coated Nifedipine Suppositories |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment |
| Official Title: | An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects |
| Study Completion Date: | April 2009 |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Coated Nifedipine Suppositories
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. |
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:
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects meeting the following criteria will be eligible to participate in the trial:
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:
Contacts and Locations
More Information
| Responsible Party: | Michael Shapiro MD, Gastroenterology Dept, Asaf Harofe Medical Center |
| ClinicalTrials.gov Identifier: | NCT00816205 History of Changes |
| Other Study ID Numbers: | RDD102 |
| Study First Received: | December 31, 2008 |
| Last Updated: | April 6, 2009 |
| Health Authority: | Israel: Ministry of Health |
|
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