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Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482037
Recruitment Status : Unknown
Verified March 2018 by Recordati Industria Chimica e Farmaceutica S.p.A..
Recruitment status was:  Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Recordati Industria Chimica e Farmaceutica S.p.A.

Brief Summary:
Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury

Condition or disease Intervention/treatment Phase
Neurogenic Detrusor Overactivity Drug: Rec 0/0438 1 mg or 2 mg Drug: placebo Phase 1 Phase 2

Detailed Description:
Multicentre, double-blind, randomised, parallel groups, placebo-controlled study to be conducted in specialized centres in Europe to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of two different doses of Rec 0/0438 in comparison with placebo, in subjects with neurogenic detrusor overactivity due to spinal cord injury.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: two sequential cohorts, each corresponding to a dose level.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Two Different Doses of Rec 0/0438 Administered by Intravesical Instillation in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury: a Repeated Doses, Double-blind, Placebo Controlled Study
Estimated Study Start Date : March 30, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rec 0/0438
Rec 0/0438 1 mg (first cohort), 2 mg (second cohort) to be administered by intravesical instillation once daily for four weeks
Drug: Rec 0/0438 1 mg or 2 mg
Each vial content will be administered via the catheter used for the self-catheterization

Placebo Comparator: Placebo
Placebo, to be administered by intravesical instillation once daily for four weeks
Drug: placebo
Each vial content will be administered via the catheter used for the self-catheterization




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: Day 28 ]
    Treatment-emergent adverse events occurred with treatment with Rec 0/0438


Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: Day 1 and Day 7 ]
    Peak Plasma Concentration (Cmax)

  2. Area Under the Curve (AUC) [ Time Frame: Day 1 and Day 7 ]
    Area under the plasma concentration versus time curve (AUC)

  3. Change from baseline in Maximum Cystometric Capacity [ Time Frame: Day 28 ]
    The volume at which uncontrollable voiding begins during filling Cystometry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged ≥18 years and ≤65 years.
  • Female subjects must be either sterile or, if with child-bearing potential, must have a pregnancy test negative and commit to the use of a highly effective method of birth control (see Appendix 15.6) for the duration of the study, and until at least 1 month after the last dose of study medication. Male subjects must be willing to use male contraception (condom) to avoid pregnancies of their female partner of childbearing potential throughout the entire duration of the study, and for 3 months after the last dose of study medication.
  • Suffering from NDO due to SCI at upper motor neuron level (below C6) and emptying the bladder performing clear intermittent self-catheterization (CISC).
  • Subjects classified in group A, B, or C, of the ASIA (American Spinal Injury Association) impairment scale.
  • Stable therapy for NDO in the last thirty days (Subjects should maintain the therapy stable for the duration of the study).
  • At least 1 incontinence episode/day despite current treatment, according to what is reported in the Bladder Diary filled in by the subject.
  • Subjects with diastolic blood pressure values between 60 and 99 mmHg (both inclusive), and systolic blood pressure values between 90 and 159 mmHg (both inclusive). Blood pressure measurement must be performed in subjects with an empty bladder.
  • Subjects with stable concomitant medication treatment at baseline.
  • Written informed consent must be given by subjects before any study related investigational procedures is performed.

Exclusion Criteria:

  • Breastfeeding women.
  • Treatment with injection of botulinum toxin, unless in the opinion of the Investigator the bladder activity has returned to pre-treatment level.
  • Use of prohibited concomitant medications, such as drugs that could affect immunoassay testing (systemic corticosteroids: prednisone, budesonide, prednisolone; calcineurin inhibitors: cyclosporine, tacrolimus; mTOR inhibitors: sirolimus, everolimus; IMDH inhibitors: azathioprine, leflunomide, mycophenolate; biologics: abatacept, adalimumab, anakinra , certolizumab, etanercept, golimumab, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab; monoclonal antibodies: basiliximab, daclizumab, muromonab) or initiation of therapy with drugs affecting lower urinary tract symptoms (such as alpha-blockers, tadalafil 5 mg oad). If already present at Screening visit, therapy with drugs affecting lower urinary tract symptoms must be maintained stable through the study period (Note: occasional treatment with PDE-5 inhibitors for erectile dysfunction should be avoided between Screening visit and Day 8 and between Day 25 and 28).
  • History of cerebro- or cardio-vascular diseases (TIA, stroke, hypertensive encephalopathy, angina pectoris, MI, cardiac by-pass, CHF NYHA classes III and IV).
  • Uncontrolled type 1 or type 2 diabetes (Hb A1c >8 %).
  • Moderate to severe renal impairment (estimated creatinine clearance <60 mL/min by the Cockcroft-Gault equation).
  • Moderate to severe liver impairment (any liver function test: AST, ALT, GGT, Bilirubin >2.5 times the upper limit of normal).
  • Hemodynamically significant valve disease, including aortic stenosis or clinically significant ventricular or supraventricular arrhythmia, heart rate >100 beats/min.
  • Clinically important abnormal laboratory findings during the run-in period, including: Haemoglobin <10 g/dL; Serum Potassium >5.5 mmol/L; Serum Sodium <132 mmol/L.
  • Symptomatic active urinary tract infection (i.e. cloudy and/or malodorous urine, chills, fever, increased muscle spasticity or increased autonomic dysreflexia, letargy, hypotension, malaise).
  • Evidence of any neoplastic disease.
  • History of allergy, hypersensitivity or intolerance to drugs.
  • Participation in an investigational drug study within 30 days prior to the screening assessment.
  • Any other diseases or conditions, that according to the Investigator's opinion, make the subject unable to comply with protocol requirements, or unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482037


Contacts
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Contact: Massimo Casi, M.D. +39024878 ext 7456 casi.m@recordati.it
Contact: Cristina Ghezzi, M.D. +39024878 ext 7480 ghezzi.c@recordati.it

Locations
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France
Department of Urology, Academic hospital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Pierre et Marie Curie Medical School, Sorbonne Universités Recruiting
Paris, France, 75013
Contact: Emmanuel Chartier Kastler, M.D.    +331 421 771 29    emmanuel.chartier-kastler@aphp.fr   
Centre Hospitalier Lyon Sud Unité de Pharmacie Clinique Oncologique (essai clinique) Pavillon Marcel Bérard - Bât. 1G Recruiting
Pierre-Bénite, France, 69495
Contact: Alain Ruffion, M.D.    +334 726 788 37    alain.ruffion@chu-lyon.fr   
Sponsors and Collaborators
Recordati Industria Chimica e Farmaceutica S.p.A.
Investigators
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Principal Investigator: Francisco Cruz, M.D. Centro Hospitalar de São João (CHSJ), Serviço de Urologia, Alameda Prof. Hernâni Monteiro, 4200-319 Porto, Portugal

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Responsible Party: Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov Identifier: NCT03482037    
Other Study ID Numbers: Rec 0/0438-IT-CL 0491
2017-000905-19 ( EudraCT Number )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries