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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00972998
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : December 29, 2009
Sponsor:
Information provided by:
RDD Pharma Ltd

Tracking Information
First Submitted Date  ICMJE August 17, 2009
First Posted Date  ICMJE September 9, 2009
Last Update Posted Date December 29, 2009
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2009)
The primary efficacy parameter is change in Resting Anal Pressure from baseline. [ Time Frame: 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2009)
  • The ratio of change in anal pressure to plasma Phenylephrine level. [ Time Frame: 8 hours ]
  • The ratio of change in anal pressure to change in blood pressure. [ Time Frame: 8 hours ]
  • The ratio of change in anal pressure to change in heart rate. [ Time Frame: 8 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
Official Title  ICMJE An Open Label Study to Examine the Effect of Coated Phenylephrine Suppositories on Anal Pressure in Healthy Subjects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Incontinence
Intervention  ICMJE Drug: Phenyephrine
Phenyephrine coated suppositories
Study Arms  ICMJE Experimental: Healthy individuals
Intervention: Drug: Phenyephrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2009)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00972998
Other Study ID Numbers  ICMJE RDD 105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Shapiro MD, Gastroenterology Dept, Asaf Harofe Medical Center
Study Sponsor  ICMJE RDD Pharma Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shlomo Shapiro, MD Dept of gastroeneterology, asaf harofe medical center
PRS Account RDD Pharma Ltd
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP