Clinical Trials Logo
  1. Home
  2. Fecal Incontinence
  3. NCT01175941

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

Fecal Incontinence Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01175941
Study type Interventional
Source Norgine
Contact
Status Completed
Phase Phase 1
Start date August 2010
Completion date December 2011
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03825575 - Sacral Neuromodulation as Treatment for Fecal Incontinence N/A
Completed NCT00605826 - A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence N/A
Withdrawn NCT02208258 - Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool. N/A
Completed NCT01957969 - French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence N/A
Completed NCT01939821 - A Pilot Study to Evaluate Educational Programs to Improve Fecal Incontinence Care in Nursing Homes N/A
Completed NCT01710579 - Normal Values in Ano-rectal 3D High Resolution Manometry N/A
Recruiting NCT00530933 - Tibial Nerve Stimulation for Faecal Incontinence N/A
Withdrawn NCT00522691 - Efficacy of Sacral Nerve Stimulation Before Definitive Implantation N/A
Completed NCT00565136 - Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms Phase 1/Phase 2
Completed NCT00677508 - Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Completed NCT05032534 - Examination of a New Irrigation System for Transanal Irrigation in Children With Fecal Incontinence N/A
Completed NCT05058326 - Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
Completed NCT03746834 - NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation Phase 4
Completed NCT00124904 - Biofeedback for Fecal Incontinence N/A
Completed NCT03028636 - LIBERATE - PRO: Eclipse™ System Registry
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1
Completed NCT05621629 - Management of FI After Surgery of ARM
Withdrawn NCT04138602 - BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence N/A
Completed NCT04478799 - Transcutaneous Posterior Nerve Stimulation inTreatment of Fecal Incontience N/A
Completed NCT03252951 - Physical Therapy for Anal Incontinence N/A