A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:July 27, 2017
End Date:March 20, 2020
Contact:Global Clinical Compliance
Email:DK0-Disclosure@ferring.com
Phone:+1 833-548-1402 (US/Canada)

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A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults

The purpose of this trial is to investigate the efficacy, safety and tolerability of
different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of
treatment for nocturia due to nocturnal polyuria in adults


Inclusion Criteria:

- Adults ≥18 years of age (at the time of written consent)

- 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:

- Current diagnosis of Obstructive Sleep Apnoea (OSA)

- 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
We found this trial at
46
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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20 West Wenger Road
Englewood, Ohio 45322
937-771-5103
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6719 Alvarado Road
San Diego, California 92120
619-287-6000
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Aventura, Florida 33180
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Bruxelles,
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Charlotte, North Carolina 28207
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Clearwater, Florida 33761
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Clearwater, Florida 33759
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Clinton, Utah 84015
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Concord, North Carolina 28025
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801 Monterey Street
Coral Gables, Florida 33134
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Denver, Colorado 80220
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Denver, Colorado 80218
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Englewood, New Jersey 07631
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Green Acres, Florida 33467
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Greenfield, Indiana 46140
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Greensboro, North Carolina 27408
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HIgh Point, North Carolina 27262
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1201 North Dairy Ashford Road
Houston, Texas 77079
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Kalamazoo, Michigan 49009
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Lincoln, California 95648
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Miami, Florida 33126
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Miami, Florida 33155
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, South Carolina 29464
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Murrieta, California 92563
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7114 Congress Street
New Port Richey, Florida 34655
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New Windsor, New York 12553
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Ogden, Utah 84405
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10040 Regency Circle
Omaha, Nebraska 68114
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Pembroke Pines, Florida 33026
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Pompano Beach, Florida 33060
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
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Providence, Rhode Island 02908
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Raleigh, North Carolina 27609
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Rochester, Michigan 48307
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Saint Petersburg, Florida 33709
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Watertown, Massachusetts 02472
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