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
NCT ID: NCT01656720
Last Updated: 2015-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
417 participants
INTERVENTIONAL
2012-02-29
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo 2g Suppository
Placebo
NRL001 5mg
5mg NRL001 in a 2g suppository
1R, 2S-methoxamine hydrochloride
NRL001 7.5mg
7.5mg NRL001 in a 2g suppository
1R, 2S-methoxamine hydrochloride
NRL001 10mg
10mg NRL001 in a 2g suppository
1R, 2S-methoxamine hydrochloride
Interventions
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1R, 2S-methoxamine hydrochloride
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Patients taking any continuous medication need to have been on a stable regimen for at least 1 month prior to Visit 1 - Screening Visit.
Exclusion Criteria
* 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).
* Vascular claudication after \<50 metres walking distance.
* Severe renal impairment defined as glomerular filtration rate (GFR) ≤ 30 ml/min, uncontrolled and reno-vascular end stage renal disease.
* Patients with diabetic polyneuropathies.
* Any type of chronic diarrhoea or frequent diarrhoea (defined as \>5 loose stools per day).
* Faecal impaction and overflow diarrhoea.
* Male patients with clinically diagnosed prostatic hyperplasia.
* Clinically significant electrolyte abnormalities, e.g. clinically significant low/high potassium and low sodium.
* Presence of clinical symptomatic haemorrhoids (grade III and IV), anal fissures or anorectal fistulas.
* Less than 2 episodes of faecal incontinence (solids, liquid, gas or mucus) per week during the 4 week historical period prior to Visit 1 - Screening Visit.
* Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
* Known history of allergy to methoxamine or any other ingredients of the Investigational Medicinal Product.
* Patients who, in the opinion of the Investigator, are unsuitable for participation in the study due to any dependencies, general medical conditions or significant illness within two weeks prior to randomisation.
* Use of any disallowed concomitant medication or other medication that the Investigator believes may affect the study including over-the-counter (OTC) products within 30 days prior to the Investigational Medicinal Product administration.
* A personal or family history of QTcf prolongation or sudden death.
* Patients taking Loperamide (2mg) \>8 tablets per day for faecal incontinence either alone or in combination with codeine phosphate and/or paracetamol (8/500mg).
* Patients using any device for the treatment of faecal incontinence.
18 Years
ALL
No
Sponsors
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Norgine
INDUSTRY
Responsible Party
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Principal Investigators
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Laurent Siproudhis, MD
Role: PRINCIPAL_INVESTIGATOR
Hopital Pontchaillou
Locations
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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
Chu Nantes - Hotel Dieu - Institut Des Maladies De L'Appareil Digestif (IMAD)
Nantes, , France
Dr Laurent Siproudhis
Rennes, , France
Chu Rouen - Hopital De Charles Nicolle
Rouen, , France
Zentrum Fur Darm-Und Beckenchirurgie
Berlin, , Germany
Martin-Luther-Krankenhaus
Berlin, , Germany
Universitats-Frauenklink
Heidelberg, , Germany
PMC Pannon Medical Center
Budapest, , Hungary
Polyclinic for Outpatients, Szakrendelo Intezet
Budapest, , Hungary
University of Debrecen, Medical and Health Science Center
Debrecen, , Hungary
University of Szeged, Albert Szent-Gyorgyi Clinical Center, Faculty of Medicine
Szeged, , Hungary
Javorszky Odon Hopsital
Vac Argenti, , Hungary
Csolnoky Ferenc Veszprem
Veszprém, , Hungary
Chirurgia Gastroenterologica
Milan, , Italy
Casa Di Cura San Pio X
Milan, , Italy
Seconda Unita Operativa Di Chirurgia Generale
Pordenone, , Italy
Dipartimento Emergenza Urgenza
Rome, , Italy
Unita Operativa Complessa Gastroenteroloogia A
Rome, , Italy
Unita Operativa Complessa Patologia Chirurgica A Indirizzo Gastroenterologico
Rome, , Italy
Nzoz Vitamed
Bydgoszcz, , Poland
General And Proctology Surgeon
Gdów, , Poland
Centrum Medyczne, Wyzszej Szkoly Informatycznej
Głowno, , Poland
Nzoz Mekmed S.C. Przychondnia Lekarska
Katowice, , Poland
Nzoz Mikomed
Lodz, , Poland
Osrodek Badawczo - Leczniczy Zbigniew Zegota
Ostróda, , Poland
Endoskopia
Sopot, , Poland
Lubelskie Centrum Diagnostyczne
Świdnik, , Poland
Lecznica Prosen SMO Private Medical Health Care Centre
Warsaw, , Poland
Ars Medica SC
Wroclaw, , Poland
Hospital Valle De Hebron
Barcelona, , Spain
Hospital Clinic De Barcelona
Barcelona, , Spain
Hospital De Mataro
Mataró, , Spain
USP, Hospital De Marbella
Málaga, , Spain
Hospital Clinico Universtiaria Lozana Blesa
Zaragoza, , Spain
Pelvic Floor Centre
Malmo, , Sweden
Kirurgiska Kliniken Universitetssjukhuset
Örebro, , Sweden
Enheten For Nedre Abdominell Kirurgi
Stockholm, , Sweden
Institute of Surgical Sciences
Uppsala, , Sweden
St Mark's Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Queens Medical Centre
Nottingham, , United Kingdom
Nothern General Hopsital
Sheffield, , United Kingdom
Countries
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Other Identifiers
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NRL001-01/2011 (SEFI)
Identifier Type: -
Identifier Source: org_study_id
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