A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults
NCT ID: NCT03201419
Last Updated: 2022-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
302 participants
INTERVENTIONAL
2017-07-27
2019-10-31
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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FE 201836 500 μg (Randomized Treatment Period)
FE 201836 500 μg oral solution and placebo orally disintegrating tablet (ODT), administered once daily
FE 201836
Oral solution for daily intake
Placebo ODT
Manufactured to mimic experimental drug
FE 201836 350 μg (Randomized Treatment Period)
FE 201836 350 μg oral solution and placebo ODT, administered once daily
FE 201836
Oral solution for daily intake
Placebo ODT
Manufactured to mimic experimental drug
FE 201836 250 μg (Randomized Treatment Period)
FE 201836 250 μg oral solution and placebo ODT, administered once daily
FE 201836
Oral solution for daily intake
Placebo ODT
Manufactured to mimic experimental drug
FE 201836 150 μg (Randomized Treatment Period)
FE 201836 150 μg oral solution and placebo ODT, administered once daily
FE 201836
Oral solution for daily intake
Placebo ODT
Manufactured to mimic experimental drug
FE 201836 100 μg (Randomized Treatment Period)
FE 201836 100 μg oral solution and placebo ODT, administered once daily
FE 201836
Oral solution for daily intake
Placebo ODT
Manufactured to mimic experimental drug
FE 201836 50 μg (Randomized Treatment Period)
FE 201836 50 μg oral solution and placebo ODT, administered once daily
FE 201836
Oral solution for daily intake
Placebo ODT
Manufactured to mimic experimental drug
Placebo (Randomized Treatment Period)
Placebo oral solution and placebo ODT, administered once daily
Placebo oral solution
Manufactured to mimic experimental drug
Placebo ODT
Manufactured to mimic experimental drug
Desmopressin 25 μg (Randomized Treatment Period)
Desmopressin 25 μg ODT and placebo oral solution, administered once daily (female subjects)
Desmopressin
Desmopressin Orally Disintegrating Tablet (ODT)
Placebo oral solution
Manufactured to mimic experimental drug
Desmopressin 50 μg (Randomized Treatment Period)
Desmopressin 50 μg ODT and placebo oral solution, administered once daily (male subjects)
Desmopressin
Desmopressin Orally Disintegrating Tablet (ODT)
Placebo oral solution
Manufactured to mimic experimental drug
Interventions
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FE 201836
Oral solution for daily intake
Desmopressin
Desmopressin Orally Disintegrating Tablet (ODT)
Placebo oral solution
Manufactured to mimic experimental drug
Placebo ODT
Manufactured to mimic experimental drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
* ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
* The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2
* Nocturnal polyuria, defined as Nocturnal Polyuria index \>33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2
* ≥20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3
Exclusion Criteria
* Restless Legs Syndrome (RLS)
* Bladder Outlet Obstruction (BOO) or urine flow \<5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2
* Urinary incontinence defined as an average of \>1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary)
* Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures
* Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms
* A history of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin
* History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, spina bifida)
* Habitual (fluid intake \>3L per day) or psychogenic polydipsia
* Uncontrolled hypertension, as judged by the investigator
* Uncontrolled diabetes mellitus, as judged by the investigator
* Central or nephrogenic diabetes insipidus
* Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion
* History of gastric retention
* Suspicion or evidence of congestive heart failure, (New York Heart Association (NYHA) class II, III, IV)
* Hyponatraemia:
* Serum sodium level \<135 mmol/L at Visit 1(re-tested, with results available within 7 days)
* Serum sodium level \<130 mmol/L at Visit 3 (re-tested, with results available within 7 days)
* Use of any prohibited therapy listed below:
* Current or former (within 3 months prior to screening) treatment with any other investigational medicinal product (IMP)
* Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable)
* Thiazide diuretics
* Antiarrhythmic agents
* V2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin)
* Loperamide
* Botulinum toxin (cosmetic non-urological use is acceptable)
* Valproate
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Coastal Clinical Research, an AMR company
Mobile, Alabama, United States
Clinical Trials Research
Lincoln, California, United States
Tri Valley Urology Medical Group
Murrieta, California, United States
San Diego Clinical Trials
San Diego, California, United States
Advanced Rx Clinical Research Group, Inc.
Westminster, California, United States
Downtown Women's Health Care
Denver, Colorado, United States
Genitourinary Surgical Consultants, P.C.
Denver, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Finlay Medical Research Corp
Greenacres City, Florida, United States
Pharmax Research Clinic
Miami, Florida, United States
Doctors Research Institute Corporation
Miami, Florida, United States
Sanitas Research
Miami, Florida, United States
Bayside Clinical Research LLC
New Port Richey, Florida, United States
Pines Care Research Center, Inc
Pembroke Pines, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Meridien Research, Inc.
St. Petersburg, Florida, United States
American Health Network of Indiana, LLC
Avon, Indiana, United States
American Health Network of Indiana, LLC
Greenfield, Indiana, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Beyer Research
Kalamazoo, Michigan, United States
Remedica LLC
Rochester, Michigan, United States
Quality Clinical Research Center, Inc.
Omaha, Nebraska, United States
Clinical Research Consortium, an AMR company
Las Vegas, Nevada, United States
Mid Hudson Medical Research, PLLC
New Windsor, New York, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States
American Health Research, Inc.
Charlotte, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
HWC Women's Research Center
Englewood, Ohio, United States
NECCR Primacare Research, LLC
Providence, Rhode Island, United States
Coastal Carolina Research Center, Inc
Mt. Pleasant, South Carolina, United States
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, United States
MCA Research - Partner
Houston, Texas, United States
Ericksen Research & Development, LLC
Clinton, Utah, United States
Advanced Research Institute
Ogden, Utah, United States
Clinical Research Associates of Tidewater, an AMR company
Norfolk, Virginia, United States
ULB Hopital Erasme
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
AZ Groeninge - Campus Vercruysselaan
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
Ultra-Med Inc.
Pointe-Claire, Quebec, Canada
Milestone Research
London, , Canada
SKDS Research Inc.
Newmarket, , Canada
Clinique Médicale St-Louis (Recherche) inc d/b/a/ Centre de Recherche Saint-Louis
Québec, , Canada
DIEX Recherche Quebec Inc.
Québec, , Canada
Bluewater Health-Norman Site
Sarnia, , Canada
CHUS - Hôpital Fleurimont
Sherbrooke, , Canada
DIEX Recherche Sherbrooke Inc.
Sherbrooke, , Canada
Ferring Investigational Site
Toronto, , Canada
DIEX Recherche Victoriaville Inc.
Victoriaville, , Canada
Urologie Benešov - Afimed s.r.o.
Benešov, , Czechia
Fakultni nemocnice Brno, Dept of Klinika nemoci plicnich a tuberkulozy
Brno, , Czechia
Krajska nemocnice Liberec, a.s.
Liberec, , Czechia
Urocentrum Plzen
Pilsen, , Czechia
Thomayerova nemocnice, PARENT
Prague, , Czechia
Gemeinschaftspraxis fuer Urologie und Andrologie
Duisburg, , Germany
Urologische Gemeinschaftspraxis
Emmendingen, , Germany
Klinikum Weiden, Klinik f. Urologie, Andrologie und Kinderurologie
Weiden, , Germany
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, , Hungary
Synexus Magyarorszag Kft.
Budapest, , Hungary
Bagoly Egeszseghaz
Kecskemét, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Urologia
Nyíregyháza, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, , Hungary
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, , Poland
Countries
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References
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Hudgens S, Howerter A, Polek E, Andersson FL. Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting. Qual Life Res. 2022 Jun;31(6):1837-1848. doi: 10.1007/s11136-021-03060-4. Epub 2021 Dec 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003851-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
000233
Identifier Type: -
Identifier Source: org_study_id
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