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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01265485
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : August 23, 2011
Information provided by (Responsible Party):
RDD Pharma Ltd

Brief Summary:

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 or disease Intervention/treatment Phase
Fecal Incontinence Drug: coated suppository Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Examine the Effect of Coated Suppositories on Anal Pressure in Healthy Subjects
Study Start Date : August 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: treatment Drug: coated suppository
Dose escalating study

Primary Outcome Measures :
  1. Change in resting anal pressure [ Time Frame: 1 day ]
    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 :
  1. Drug absorption [ Time Frame: 1 day ]
    Blood samples for determining drug absorption be taken at times 0, 30, 60, 120, 180, 300 minutes after administration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01265485

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

Responsible Party: RDD Pharma Ltd Identifier: NCT01265485     History of Changes
Other Study ID Numbers: RDD 107
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011

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