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

NCT00972998 | Completed Phase 1

• 1 other identifier: RDD 105
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

anal sphincter pressure; phenyephrine

Outcome Measures

Primary Outcomes (1)

• The primary efficacy parameter is change in Resting Anal Pressure from baseline.

  8 hours

Secondary Outcomes (3)

• 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

Study Arms (1)

Healthy individuals

EXPERIMENTAL

Drug: Phenyephrine

Interventions

Phenyephrine DRUG

Phenyephrine coated suppositories

Healthy individuals

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RDD Pharma Ltd: lead

Study Sites (1)

Dept of Gastroeneterology, Asaf Harofe Medical Center

Zrifin, 70300, Israel

Location

Study Officials

• Shlomo Shapiro, MD

  Dept of gastroeneterology, asaf harofe medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 29, 2009

Record last verified: 2009-12

Locations

IL (1)