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

NCT00972998 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2009-12-29

No results posted yet for this study

Summary

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.

Conditions

  • Incontinence

Interventions

DRUG

Phenyephrine

Phenyephrine coated suppositories

Sponsors & Collaborators

  • RDD Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Shlomo Shapiro, MD · Dept of gastroeneterology, asaf harofe medical center

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Israel

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00972998 on ClinicalTrials.gov