Status:
COMPLETED
Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.
Lead Sponsor:
Norgine
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a healthy volunteer three-way crossover study. A total of 12 subjects will receive three single administrations of 1 g rectal suppositories (containing either 5 mg NRL001, 10 mg NRL001 or matc...
Eligibility Criteria
Inclusion
- No previous history of ano-rectal conditions or diseases
- No history of cardiovascular disease
- 18 to 60 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, or use of any medication currently or within the last 30 days which the Investigator believes may affect the study participation or results
- Use of monoamine oxidase inhibitors presently or within the last 2 weeks before study participation
- Use of any medication in the last 30 days applied to the anus and/or via the rectum
- Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last three months which involved being paid a disturbance allowance; having an invasive procedure (e.g. venepuncture \>50ml, endoscopy) or exposure to ionising radiation.
- 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 160 mmHg or diastolic blood pressure greater than 90 mmHg; 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 or lactating females
- History of any clinically relevant allergy
- 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 comply with the requirements of the trial
- Volunteers who have been exposed to more than 5 mSv of ionising radiation in the last 12 months.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00857467
Start Date
February 1 2009
Last Update
December 23 2009
Active Locations (1)
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1
Department of GI Surgery, Nottingham University Hospital
Nottingham, United Kingdom, NG7 2UH