Status:
COMPLETED
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
Lead Sponsor:
Norgine
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00893607
Start Date
April 1 2007
End Date
December 1 2007
Last Update
May 6 2009
Active Locations (1)
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1
Division of GI Surgery, University Hospital - Queens Medical Centre
Nottingham, United Kingdom, NG7 2UH