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

Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972998
• Other study ID #: RDD 105
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 17, 2009
• Last updated: December 28, 2009
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: RDD Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Incontinence

Intervention

Drug:
• Phenyephrine
Phenyephrine coated suppositories

Locations

Country	Name	City	State
Israel	Dept of Gastroeneterology, Asaf Harofe Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
RDD Pharma Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy parameter is change in Resting Anal Pressure from baseline.		8 hours	No
Secondary	The ratio of change in anal pressure to plasma Phenylephrine level.		8 hours	Yes
Secondary	The ratio of change in anal pressure to change in blood pressure.		8 hours	Yes
Secondary	The ratio of change in anal pressure to change in heart rate.		8 hours	Yes