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

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
NRL001
Sponsored by
Norgine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Division of GI Surgery, University Hospital - Queens Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intra-anal

Rectal

Arm Description

The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal.

The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository.

Outcomes

Primary Outcome Measures

Change in mean anal resting pressure (MARP)

Secondary Outcome Measures

Pharmacokinetics of NRL001 in plasma
Monitoring of blood pressure and heart rate

Full Information

First Posted
May 5, 2009
Last Updated
May 5, 2009
Sponsor
Norgine
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1. Study Identification

Unique Protocol Identification Number
NCT00893607
Brief Title
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Norgine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-anal
Arm Type
Experimental
Arm Description
The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal.
Arm Title
Rectal
Arm Type
Experimental
Arm Description
The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository.
Intervention Type
Drug
Intervention Name(s)
NRL001
Other Intervention Name(s)
Methoxamine Hydochloride
Intervention Description
10mg NRL001 was administered as a slow release suppository
Primary Outcome Measure Information:
Title
Change in mean anal resting pressure (MARP)
Time Frame
Up to 6 hours post-dose
Secondary Outcome Measure Information:
Title
Pharmacokinetics of NRL001 in plasma
Time Frame
Up to 6 hours post-dose
Title
Monitoring of blood pressure and heart rate
Time Frame
Up to 6 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John H Scholefield
Organizational Affiliation
University Hospital - Queens Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of GI Surgery, University Hospital - Queens Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

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

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