Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum

Phase 1

Completed

• Conditions: Fecal Incontinence
• Interventions: Drug: NRL001

• Registration Number: NCT00893607
• Lead Sponsor: Norgine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2007-08
• Study Completion: 2007-12
• Status Verified: 2009-05
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-05
• Last Update Submitted: 2009-05-05
• Study First Posted: 2009-05-06
• Last Update Posted: 2009-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intra-anal	NRL001	The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal.
Rectal	NRL001	The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository.

Primary Outcome Measures

Name	Time	Method
Change in mean anal resting pressure (MARP)	Up to 6 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of NRL001 in plasma	Up to 6 hours post-dose
Monitoring of blood pressure and heart rate	Up to 6 hours post-dose

Trial Locations

Locations (1)

Division of GI Surgery, University Hospital - Queens Medical Centre; 🇬🇧 Nottingham, United Kingdom