NCT01175941

Effect of 7 Days of Dosing With a 10 mg Rectal Suppository of NRL001in Patients With Faecal Incontinence

A Double-blind, Randomized, Placebo-controlled, Cross Over Study in Patient Volunteers With Faecal Incontinence to Evaluate the Effect on Rectal Compliance, Rectal Sensitivity, Recto-anal Inhibitory Reflex, Sphincter Pressures, Safety and Tolerability of a Daily Rectal Application of a 10 mg NRL001 Suppository for Seven Consecutive Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a study to examine the effect of alpha adrenergic stimulation of the anal canal and rectum on parameters affecting the control of defecation in subjects with faecal incontinence. The study will investigate the effects of rectal suppositories containing 10 mg NRL001 given for seven days, once daily. Rectal compliance and median anal resting pressure will be considered the primary objective of the study. A pharmacokinetic evaluation plus safety and tolerability assessment including monitoring of electrocardiograms (ECGs), blood pressure and heart rate will also be evaluated as secondary objectives.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	NRL001	10 mg NRL001 in a 2 g suppository, administered once daily for 7 days
DRUG	Placebo control	Matched placebo - administered as a 2 g suppository, once daily for 7 days

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2010-08-05
• Last updated: 2012-11-05

Locations

1 site across 1 country: United Kingdom