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Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Males Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01262456
First received: December 15, 2010
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males


Condition Intervention Phase
Nocturia
 Drug: Desmopressin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Reduction of mean number nocturnal voids relative to baseline [ Time Frame: 3 months of treatment compared to Baseline ] [ Designated as safety issue: No ]
  • A decrease of at least 33% in the mean number of nocturnal voids [ Time Frame: 3 months of treatment compared to Baseline ] [ Designated as safety issue: No ]
  • Reduction of mean number nocturnal voids relative to baseline [ Time Frame: 4 months of treatment compared to Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction mean number of night voids based on the three-days diary [ Time Frame: 3 months of treatment compared to Baseline ] [ Designated as safety issue: No ]
  • Change in time to first void based on the three-days diary [ Time Frame: 3 months of treatment compared to Baseline ] [ Designated as safety issue: No ]
  • Change in nocturnal urine volume and 24-hour urine volume based on the three-days diary [ Time Frame: 3 months of treatment compared to Baseline ] [ Designated as safety issue: No ]
  • Incidence of hyponatraemia as measured by serum sodium level throughout the trial [ Time Frame: from end of the first week up to three months in Double-blind part ] [ Designated as safety issue: Yes ]
  • Incidence of hyponatraemia as measured by serum sodium level throughout the trial [ Time Frame: from end of the first week up to one month in Open-label part ] [ Designated as safety issue: Yes ]

Enrollment: 392
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2. Drug: Desmopressin
Placebo Comparator: 3. Drug: Placebo
Experimental: 1. Drug: Desmopressin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to performance of any trial-related activity
  • Female sex 18 years of age or older
  • At least two voids every night in a consecutive three-day period during the screening period

Exclusion Criteria:

  • Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than one episode/day), Urgency (more than one episode/day), Frequency (more than eight daytime voids/day)
  • Recurring discomfort or pain in the bladder (chronic bladder inflammation)
  • Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
  • Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past six months
  • Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
  • Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)
  • Diabetes caused by damage to the pituitary gland or kidney disease
  • Any condition in which the body develops an excess of water and a decrease in sodium (salt) concentration
  • Current or a history of urologic malignancies e.g. bladder cancer
  • Genito-urinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms
  • Malfunctioning urinary bladder due to neurologic dysfunction
  • Suspicion or evidence of cardiac failure
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Hyponatraemia: Serum sodium level must be within normal limits
  • Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
  • Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL.
  • History of obstructive sleep apnea
  • Previous desmopressin treatment for nocturia
  • Treatment with another investigational product within three months prior to screening
  • Concomitant treatment with any prohibited medication* Prohibited therapy: Loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug.
  • Known alcohol or substance abuse
  • Work or lifestyle that may interfere with regular night-time sleep e.g. shift workers
  • Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier which, in the judgement of the Investigator, would impair participation in the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262456

  Show 56 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01262456     History of Changes
Other Study ID Numbers: FE992026 CS41
Study First Received: December 15, 2010
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Nocturia
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013