An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
RDD Pharma Ltd
ClinicalTrials.gov Identifier:
NCT00816205
First received: December 31, 2008
Last updated: April 6, 2009
Last verified: April 2009
  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 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by RDD Pharma Ltd:

Primary Outcome Measures:
  • The primary efficacy parameter is change in Resting Anal Pressure from baseline. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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.


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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816205

Locations
Israel
Dept of Gastroeneterology, Asaf Harofe Medical Center
Zrifin, Israel
Sponsors and Collaborators
RDD Pharma Ltd
  More Information

No publications provided

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

Additional relevant MeSH terms:
Nifedipine
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 28, 2014