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

An Open Label Study to Examine the Effect of Coated Phenylephrine 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.

A screening will be used to determine subject suitability for inclusion in the trial. 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 Phenylephrine suppositories at various doses) will be administered at pre-determined intervals.

Study Overview

• Status: Completed
• Conditions: Incontinence
• Intervention / Treatment: Drug: Phenyephrine

Detailed Description

This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. A screening will be used to determine subject 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 a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Phenylephrine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Phenylephrine analysis.After determining baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 1 Coated Suppository per study. 60, 120 and 240 minutes after the coated suppository insertion amnometric studies will be performed: The first 2 subjects in the study will receive 40 mg phenyephrine coated suppositories. If significant (> 15%) increase in the resting anal pressure will occur with this dose, the rest of the study subjects will receive the same dose. If the raise in the resting anal pressure will not be significant AND no adverse events was observed, than the following subjects will receive 80 mg phenylehprine coated suppositories.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Zrifin, Israel, 70300
    • Dept of Gastroeneterology, Asaf Harofe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Active or chronic disease.
• In need of chronic use of medication, with the exception of birth control medications.
• Currently uses medication for acute illness.
• Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin, Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
• Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
• 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
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy individuals	Drug: Phenyephrine; Phenyephrine coated suppositories

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary efficacy parameter is change in Resting Anal Pressure from baseline.	8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
The ratio of change in anal pressure to plasma Phenylephrine level.	8 hours
The ratio of change in anal pressure to change in blood pressure.	8 hours
The ratio of change in anal pressure to change in heart rate.	8 hours

Collaborators and Investigators

• Sponsor: RDD Pharma Ltd
• Investigators: Principal Investigator: Shlomo Shapiro, MD, Dept of Gastroeneterology, Asaf Harofe Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 17, 2009
• First Submitted That Met QC Criteria: September 7, 2009
• First Posted (Estimate): September 9, 2009

Study Record Updates

• Last Update Posted (Estimate): December 29, 2009
• Last Update Submitted That Met QC Criteria: December 28, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: anal sphincter pressure; phenyephrine
• Other Study ID Numbers: RDD 105