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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RDD Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01265485
First received: December 7, 2010
Last updated: August 21, 2011
Last verified: August 2011
History of Changes
  Purpose

This is an open label, dose-finding, 2-parts study. Approximately 6 subjects will be participating in this study. This study is composed of 2 parts:

Part 1 is a dose finding study. Part 2 is a pharmacodynamic and pharmacokinetic study of an elected dose. A screening will be used to determine patients' suitability for inclusion in the trial. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose escalation. During this part, patients will undergo rectal manometry to determine anal pressure at baseline. Afterwards coated suppositories at various drug concentrations will be inserted and follow up manometries will be performed to determine response.

Patients that presented with an increase in rectal resting pressure without adverse events will enter the second part of the study. In this part, patients will be administered with a coated suppository, at a dose found at part 1 of the study to cause significant anal contraction. Manometry studies will be performed before insertion (baseline) and at 1, 3 and 5 hours after insertion.

Blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after administration.


Condition Intervention Phase
Fecal Incontinence
 Drug: coated suppository
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects

Further study details as provided by RDD Pharma Ltd:

Primary Outcome Measures:
  • Change in resting anal pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The primary outcome is the change in resting anal pressure as measured 90 minutes after insertion of coated suppository and in comparison to baseline measurement taken before intervention.


Secondary Outcome Measures:
  • Drug absorption [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Blood samples for determining drug absorption be taken at times 0, 30, 60, 120, 180, 300 minutes after administration


Estimated Enrollment: 6
Study Start Date: August 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment Drug: coated suppository
Dose escalating study

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed written informed consent.
  • Male or female subjects 18 to 55 years of age;

Exclusion Criteria:

  • Known allergy to the active drug or excipients.
  • Pregnancy or lactation.
  • Active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
  • Type 1 diabetes mellitus;
  • Insulin treated type 2 diabetes mellitus;
  • Renal insufficiency.
  • Liver insufficiency.
  • Malignant disease within 5 years of screening;
  • History of rectal surgery.
  • History of HIV, hepatitis B, hepatitis C.
  • Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
  • Chronic use of medications with the exception of birth control pills.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265485

Locations
Israel
Gastroeneterology dept, Asaf harofe Medical center
Zrifin, Israel
Sponsors and Collaborators
RDD Pharma Ltd
Investigators
Principal Investigator: Michael Shapiro, MD Gastroenetrology dept, Asaf Harofe Medical Center
  More Information

No publications provided

Responsible Party: RDD Pharma Ltd
ClinicalTrials.gov Identifier: NCT01265485     History of Changes
Other Study ID Numbers: RDD 107
Study First Received: December 7, 2010
Last Updated: August 21, 2011
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013