Clinical trial NCT00893607: Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fecal Incontinence
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2009-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 of NRL001 in plasma, adverse events, and any changes in heart rate or blood pressure were to be assessed.


Eligibility criteria: 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

Primary outcomes:
measure: Change in mean anal resting pressure (MARP)
timeFrame: Up to 6 hours post-dose
Secondary outcomes:
measure: Pharmacokinetics of NRL001 in plasma
timeFrame: Up to 6 hours post-dose
measure: Monitoring of blood pressure and heart rate
timeFrame: Up to 6 hours post-dose
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Division of GI Surgery, University Hospital - Queens Medical Centre
Study officials:
affiliation: University Hospital - Queens Medical Centre
name: John H Scholefield
role: PRINCIPAL_INVESTIGATOR
References: