Faecal Incontinence
Conditions
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 of NRL001 and subject safety are also examined.
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 pharmacokinetics of NRL001 and subject safety are also examined. The study consists of four parts, which evaluate different NRL001 concentrations and sites of application. Treatments consist of a single local application of either 0.3%, 1% or 3% w/w NRL001 gel applied peri-anally, of either 1% or 3% w/w NRL001 gel applied intra-anally, or 1% w/w NRL001 administered rectally. In addition, a 10 mg NRL001-containing suppository applied to the rectum is assessed.
Interventions
DRUGNRL001: 10mg suppository
NRL001 10mg suppository applied to rectum.
DRUGPerianal NRL001 Gel 3 strengths
A single application of 0.3%, 1.0%, 3.0% NRL001 gel in stepwise dose ascending fashion.
DRUGIntraanal NRL001 Gel 2 strengths
A single application of 3.0% or 1.0% Gel
DRUGIntrarectal NRL001 Gel
A single application of 1.0% Gel
Sponsors
Norgine
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean anal resting pressure | Six hours at visit 2 | Mean anal resting pressure (MARP) was recorded using anal manometric catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure (mmHg) | Six hours at visit 2 | Blood pressure was measured before the application of the trial medication and then every 30 minutes for the first 2 hours after application, plus 2 hourly for the remaining follow-up period. |
| Pulse rate (beats per minute) | Six hours at visit 2 | Pulse rate was measured before the application of the trial medication and then every 30 minutes for the first 2 hours after application, plus 2 hourly for the remaining follow-up period. |
Countries
United Kingdom
Outcome results
None listed