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

This study has been completed.
Sponsor:
Information provided by:
RDD Pharma Ltd
ClinicalTrials.gov Identifier:
NCT00972998
First received: August 17, 2009
Last updated: December 28, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Incontinence
Drug: Phenyephrine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open Label Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by RDD Pharma Ltd:

Primary Outcome Measures:
  • The primary efficacy parameter is change in Resting Anal Pressure from baseline. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The ratio of change in anal pressure to plasma Phenylephrine level. [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
  • The ratio of change in anal pressure to change in blood pressure. [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
  • The ratio of change in anal pressure to change in heart rate. [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy individuals Drug: Phenyephrine
Phenyephrine coated suppositories

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972998

Locations
Israel
Dept of Gastroeneterology, Asaf Harofe Medical Center
Zrifin, Israel, 70300
Sponsors and Collaborators
RDD Pharma Ltd
Investigators
Principal Investigator: Shlomo Shapiro, MD Dept of gastroeneterology, asaf harofe medical center
  More Information

No publications provided

Responsible Party: Michael Shapiro MD, Gastroenterology Dept, Asaf Harofe Medical Center
ClinicalTrials.gov Identifier: NCT00972998     History of Changes
Other Study ID Numbers: RDD 105
Study First Received: August 17, 2009
Last Updated: December 28, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by RDD Pharma Ltd:
anal sphincter pressure
phenyephrine

Additional relevant MeSH terms:
Phenylephrine
Oxymetazoline
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on April 14, 2014