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

Fecal Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893607
• Other study ID #: NRL001-01/2006 (SUPP)
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2009
• Last updated: May 5, 2009
• Start date: April 2007
• Est. completion date: December 2007

Study information

• Verified date: May 2009
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Drug:
• NRL001
10mg NRL001 was administered as a slow release suppository

Locations

Country	Name	City	State
United Kingdom	Division of GI Surgery, University Hospital - Queens Medical Centre	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean anal resting pressure (MARP)		Up to 6 hours post-dose	No
Secondary	Pharmacokinetics of NRL001 in plasma		Up to 6 hours post-dose	No
Secondary	Monitoring of blood pressure and heart rate		Up to 6 hours post-dose	Yes