Status:
COMPLETED
The Safety and Dose Response to Single Anal Doses of NRL001
Lead Sponsor:
Norgine
Conditions:
Faecal Incontinence
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics ...
Detailed Description
This is a single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmac...
Eligibility Criteria
Inclusion
- No previous history of ano-rectal conditions/diseases.
- No history of heart disease.
- 18 to 75 years of age.
- Males and females but 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 vasodilatory activity.
- Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in Part A, Part B or Part C of NRL001-01/2002(HV)
- Regular intake of more than 21 units of alcohol per week.
- 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 :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06593743
Start Date
December 1 2002
End Date
November 12 2013
Last Update
September 19 2024
Active Locations (1)
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1
University Hospital - Queens Medical Centre
Nottingham, United Kingdom, NG7 2UH