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

NCT ID: NCT00972998

Last Updated: 2009-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Incontinence

Keywords

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anal sphincter pressure phenyephrine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Healthy individuals

Group Type EXPERIMENTAL

Phenyephrine

Intervention Type DRUG

Phenyephrine coated suppositories

Interventions

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Phenyephrine

Phenyephrine coated suppositories

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RDD Pharma Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Gastroenterology Dept, Asaf Harofe Medical Center

Principal Investigators

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Shlomo Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of gastroeneterology, asaf harofe medical center

Locations

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Dept of Gastroeneterology, Asaf Harofe Medical Center

Zrifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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RDD 105

Identifier Type: -

Identifier Source: org_study_id