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

NCT01175941 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-11-05

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Jonathan A Simpson, MD · Nottingham University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01175941 on ClinicalTrials.gov