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

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00893607
First received: May 5, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 5, 2009
May 5, 2009
April 2007
August 2007   (final data collection date for primary outcome measure)
Change in mean anal resting pressure (MARP) [ Time Frame: Up to 6 hours post-dose ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Pharmacokinetics of NRL001 in plasma [ Time Frame: Up to 6 hours post-dose ] [ Designated as safety issue: No ]
  • Monitoring of blood pressure and heart rate [ Time Frame: Up to 6 hours post-dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fecal Incontinence
Drug: NRL001
10mg NRL001 was administered as a slow release suppository
Other Name: Methoxamine Hydochloride
  • Experimental: Intra-anal
    The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal.
    Intervention: Drug: NRL001
  • Experimental: Rectal
    The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository.
    Intervention: Drug: NRL001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00893607
NRL001-01/2006 (SUPP)
No
Dr Hans-Jürgen Gruss, Norgine Ltd
Norgine
Not Provided
Principal Investigator: John H Scholefield University Hospital - Queens Medical Centre
Norgine
May 2009

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