Clinical trial NCT00972998: Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
Official title: An Open Label Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Incontinence
Keywords: anal sphincter pressure
phenyephrine
Lead sponsor: RDD Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary efficacy parameter is change in Resting Anal Pressure from baseline.
timeFrame: 8 hours
Secondary outcomes:
measure: The ratio of change in anal pressure to plasma Phenylephrine level.
timeFrame: 8 hours
measure: The ratio of change in anal pressure to change in blood pressure.
timeFrame: 8 hours
measure: The ratio of change in anal pressure to change in heart rate.
timeFrame: 8 hours
Other outcomes:
Locations:
city: Zrifin
country: Israel
facility: Dept of Gastroeneterology, Asaf Harofe Medical Center
Study officials:
affiliation: Dept of gastroeneterology, asaf harofe medical center
name: Shlomo Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References: