- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03482037
Effects of Rec 0/0438 in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury
January 26, 2021 updated by: RECORDATI GROUP
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
Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Praha, Czechia
- Recordati Investigative Site
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Paris, France, 75013
- Department of Urology, Academic hospital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Pierre et Marie Curie Medical School, Sorbonne Universités
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Pierre-Bénite, France, 69495
- Centre Hospitalier Lyon Sud Unité de Pharmacie Clinique Oncologique (essai clinique) Pavillon Marcel Bérard - Bât. 1G
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Rouen, France
- Recordati Investigative Site
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Toulouse, France
- Recordati Investigative Site
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Piaseczno, Poland
- Recordati Investigative Site
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Rzeszów, Poland
- Recordati Investigative Site
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Warszawa, Poland
- Recordati Investigative Site
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Porto, Portugal
- Recordati Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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Each vial content will be administered via the catheter used for the self-catheterization
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Placebo Comparator: Placebo
Placebo, to be administered by intravesical instillation once daily for four weeks
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Each vial content will be administered via the catheter used for the self-catheterization
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of treatment-emergent adverse events
Time Frame: Day 28
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Treatment-emergent adverse events occurred with treatment with Rec 0/0438
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Day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Maximum Plasma Concentration (Cmax)
Time Frame: Day 1 and Day 7
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Peak Plasma Concentration (Cmax)
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Day 1 and Day 7
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Area Under the Curve (AUC)
Time Frame: Day 1 and Day 7
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Area under the plasma concentration versus time curve (AUC)
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Day 1 and Day 7
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Change from baseline in Maximum Cystometric Capacity
Time Frame: Day 28
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The volume at which uncontrollable voiding begins during filling Cystometry
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Day 28
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francisco Cruz, M.D., Hospital São João, Urologia, Alameda Prof. Hernâni Monteiro, 4200-319 Porto, Portugal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2018
Primary Completion (Actual)
March 27, 2019
Study Completion (Actual)
March 27, 2019
Study Registration Dates
First Submitted
March 8, 2018
First Submitted That Met QC Criteria
March 22, 2018
First Posted (Actual)
March 29, 2018
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rec 0/0438-IT-CL 0491
- 2017-000905-19 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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