The Safety and Dose Response to Single Anal Doses of NRL001

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

July 31, 2004

Study Completion Date

November 12, 2013

Conditions
Faecal Incontinence
Interventions
DRUG

Perianal NRL001 Gel 3 strengths

A single application of 0.3%, 1.0%, 3.0% NRL001 gel in stepwise dose ascending fashion.

DRUG

Intraanal NRL001 Gel 2 strengths

A single application of 3.0% or 1.0% Gel

DRUG

Intrarectal NRL001 Gel

A single application of 1.0% Gel

DRUG

NRL001: 10mg suppository

NRL001 10mg suppository applied to rectum.

Trial Locations (1)

NG7 2UH

University Hospital - Queens Medical Centre, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Norgine

INDUSTRY