Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum

May 5, 2009 updated by: Norgine

Proof of Concept Study in Healthy Volunteers to Investigate the Safety and Response to a Single Dose of 10mg Methoxamine (NRL001) Applied Locally Using a Suppository to the Anal Canal or Rectum

Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum. In addition, the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or blood pressure were to be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nottingham, United Kingdom, NG7 2UH
        • Division of GI Surgery, University Hospital - Queens Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No previous history of ano-rectal conditions/ diseases
  • No history of cardiovascular disease
  • 18 to 75 years of age
  • Males and females (pre-menopausal females of child-bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study)

Exclusion Criteria:

  • Use of medication in the last 30 days with a vasodilatory activity
  • Use of monoamine oxidase inhibitors (MAOI) presently or within the last two weeks before study participation
  • Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in NRL001-01/2006 (SUPP) for previous dosing into the anal canal)
  • Application of any unlicensed medication within the previous 3 months (exception: participation in NRL001-01/2006 (SUPP))
  • Regular intake of more than 21 units of alcohol per week
  • History or any evidence of cardiovascular disease including ischaemic heart disease and hypertension (defined on examination: systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 90mmHg; based on at least two separate readings), peripheral vascular disease or Raynaud's syndrome
  • Presence of diabetes mellitus
  • History or symptoms of thyroid diseases, including hypo- or hyperthyroidism
  • Pregnant females
  • Breast feeding mothers
  • Presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac) dysfunction
  • Volunteers whom the investigator feels would not be compliant with the requirements of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra-anal
The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal.
10mg NRL001 was administered as a slow release suppository
Other Names:
  • Methoxamine Hydochloride
Experimental: Rectal
The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository.
10mg NRL001 was administered as a slow release suppository
Other Names:
  • Methoxamine Hydochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mean anal resting pressure (MARP)
Time Frame: Up to 6 hours post-dose
Up to 6 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of NRL001 in plasma
Time Frame: Up to 6 hours post-dose
Up to 6 hours post-dose
Monitoring of blood pressure and heart rate
Time Frame: Up to 6 hours post-dose
Up to 6 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: John H Scholefield, University Hospital - Queens Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 5, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 6, 2009

Last Update Submitted That Met QC Criteria

May 5, 2009

Last Verified

May 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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