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A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period

NCT01656720•Norgine

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of NRL001 in the treatment of faecal incontinence, compared against placebo

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•An ultrasound assessment of the internal anal sphincter within the previous 12 months confirming an intact circular internal sphincter with minimal scars (maximum 60 degrees scarring circumferentially).
•Diagnosis of faecal incontinence with a Wexner score of 8 - 20 inclusive at Visit 1 - Screening Visit.
•Historical clinical evidence (past 6 months prior to Visit 1 - Screening Visit) of faecal incontinence episodes (solids, liquid, gas or mucus).
•Greater than or equal to two faecal incontinence episodes (solids, liquid, gas or mucus) per week during the 4 week historical period prior to Visit 1 - Screening Visit.
•Able and willing to receive rectal examinations and treatments.
•Patients must be aged \>18 without significant acute or uncontrolled chronic disease.
•Patients must understand the purpose and risks of the study and be able to provide written informed consent and willing, able and competent to complete the entire study and comply with study instructions as defined in the protocol.
•Female patients must be postmenopausal (for at least one year and confirmed by serum FSH at screening), or surgically sterile, practicing true sexual abstinence, or using Investigator-approved methods of contraception throughout the study until after the post study physical examination and have a negative pregnancy test at screening.
•Sexually active male patients must use condoms with their partners throughout the study and for 90 days after completion of the study in addition to their partner's normal mode of contraception.
•Male patients must not donate sperm during the study and for 90 days after the completion of the study.
+1 more criteria

Exclusion Criteria

•External anal sphincter disruption related to faecal incontinence caused by trauma.
•Patients with complicating gastrointestinal (GI) disease including those with inflammatory bowel diseases, patients that have received radiotherapy or surgery for anal cancer, patients with rectal prolapse, transanal surgery.
•Relevant history of or presence of any significant or uncontrolled cardiovascular risk including:
•1. Systolic \> 160mmHg or Diastolic \> 100mmHg. Patients on a stable regimen for \> 3 months with controlled hypertension prior to Visit 1 - Screening Visit (Systolic \< 140mmHg or Diastolic \< 90mmHg) can be included.
•2. Abnormal 24 hour Screening Holter: corrected QT interval (QTcf) prolongation with cut-off values of \>460 ms for females and \>430 ms for males, acute arrhythmia, nocturnal bradycardia with heart rate (HR) \< 40bpm, atrial fibrillation, AV block Type II and III, Sick Sinus Syndrome, vasovagal syncope.
•3. Fixed cardiac output states (severe aortic stenosis (AS), hypertrophic obstructive cardiomyopathy (HOCM).
•4. Significant mitral regurgitation (MR).
•5. Cardiac failure (New York Heart Association (NYHA) stage II-IV).
•Severe or uncontrolled asthma or chronic obstructive pulmonary disease determined by clinical history, physical examination, lung function tests or exercise tolerance
•Chronic liver disease (e.g. liver cirrhosis, chronic hepatitis, severe hepatic insufficiency).
+16 more criteria

Locations (51)

Fakultni Nemocnice BRNO

Brno, Czechia

Gastroenterologie S R O

Hradec Králové, Czechia

Krajska Nemocnice Liberec

Liberec, Czechia

Fakulni Nemocnice Kralovske

Prague, Czechia

Egk S.R.O Sanatoriu< Sv

Prague, Czechia

GEP Clinic S.R.O

Prague, Czechia

Fakultni Nemocnice V Motole

Prague, Czechia

Fakultni Nemocnice Na Bulovce, Gynekologicko-Porodnicka Klinika

Prague, Czechia

Chu Bordeaux - Hopital St Andre

Bordeaux, France

Chu Lyon Groupement Hospitalier Edouard Herriot

Lyon, France

Key Dates

Start Date

February 1, 2012

Primary Completion Date

December 1, 2013

Completion Date

September 1, 2014

Last Updated

June 9, 2015

Enrollment

417

ACTUAL participants

Conditions

Faecal Incontinence

Interventions

1R, 2S-methoxamine hydrochloride

DRUG

Placebo

DRUG

The Safety and Dose Response to Single Anal Doses of NRL001

NCT06593743

Faecal Incontinence

View study

COMPLETEDNA

The Multi-disciplinary Treatment of Functional Gut Disorders Study

NCT03078634

Irritable Bowel SyndromeFunctional Dyspepsia+4 more

View study

UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period

Inclusion Criteria

Exclusion Criteria

The Safety and Dose Response to Single Anal Doses of NRL001

The Multi-disciplinary Treatment of Functional Gut Disorders Study

Pelvipower for Faecal Incontinence

Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls

Anal Canal Functional Assessment Using EndoFLIP

Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter