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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00477490
First received: May 22, 2007
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.


Condition Intervention Phase
Nocturia
Drug: desmopressin acetate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center Study With a Double Blind Extension Investigating the Efficacy and Safety of a Fast- Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in mean number of nocturnal voids [ Time Frame: week 4 ] [ Designated as safety issue: No ]
  • Proportion of subjects with greater than 33 percent reduction from baseline in mean number of nocturnal voids [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Durability of effect in mean number of nocturnal voids [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in total sleep time [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]
  • Change from baseline in initial period of undisturbed sleep [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]
  • Change from baseline in Quality of Life [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]
  • Change from baseline in quality of sleep [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]
  • Treatment safety [ Time Frame: months 1-6 ] [ Designated as safety issue: No ]

Enrollment: 754
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants will take a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients will be randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: Placebo
Oral placebo placed under the participants tongue, without water, once daily about one hour before bedtime.
Experimental: desmopressin melt 10 μg
Participants will take desmopressin melt 10 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in study part 2 for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: desmopressin acetate
10 µg oral lyophilisate placed under the participants tongue, without water, once daily about one hour before bedtime.
Other Name: Minirin® Melt
Experimental: desmopressin melt 25 μg
Participants will take desmopressin melt 25 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in study part 2 for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: desmopressin acetate
25 µg oral lyophilisate placed under the participants tongue, without water, once daily about one hour before bedtime.
Other Name: Minirin® Melt
Experimental: desmopressin melt 50 μg
Participants will take desmopressin melt 50 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in study part 2 for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: desmopressin acetate
50 µg oral lyophilisate placed under the participants tongue, without water, once daily about one hour before bedtime.
Other Name: Minirin® Melt
Experimental: desmopressin melt 100 μg
Participants will take desmopressin melt 100 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in study part 2 for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Drug: desmopressin acetate
100 µg oral lyophilisate placed under the participants tongue, without water, once daily about one hour before bedtime.
Other Name: Minirin® Melt

  Eligibility

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

Inclusion Criteria

  1. Written informed consent prior to the performance of any study-related activity.
  2. Patients 18 years and older with an average of ≥ 2 nocturnal voids per night as determined by a 3 day voiding diary

Exclusion Criteria:

Males:

  1. Clinical suspicion of bladder outlet obstruction and/or urine flow < 5 ml/s. If medical history and/or physical examination suggest bladder outlet obstruction, uroflowmetry should be performed to confirm the diagnosis
  2. Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months

    Females:

  3. Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception.
  4. Use of pessary for pelvic prolapse
  5. Unexplained pelvic mass

    Males and Females:

  6. Clinical suspicion of urinary retention and/or post void residual volume > 150 ml. If medical history and/or physical examination suggest urinary retention, post void bladder ultrasound or catheterization should be performed to confirm the diagnosis
  7. Current or past urologic malignancy (e.g. bladder cancer, prostate cancer, etc.)
  8. Clinical evidence of current genito-urinary tract pathology (e.g. infection, stone, tumor, etc.)
  9. Neurogenic detrusor activity (previously known as detrusor hyperreflexia)
  10. Suspicion or evidence of cardiac failure
  11. Uncontrolled hypertension
  12. Uncontrolled diabetes mellitus
  13. Renal insufficiency. Serum creatinine must be within normal limits.
  14. Active hepatic and/or biliary disease. Aspartate transaminase (AST) or alanine transaminase (ALT) should not be >2 times the upper limit of normal. Total bilirubin should not be > 1.5 mg/dL.
  15. Hyponatremia. Serum sodium level must be within normal limits
  16. Syndrome of Inappropriate antidiuretic hormone secretion (SIADH) secretion
  17. Diabetes insipidus (urine output > 40 ml/kg over 24 hours) as determined by the 3 day voiding diary
  18. Psychogenic or habitual polydipsia
  19. Obstructive sleep apnea
  20. Hyperkinetic limb disorders (e.g. restless leg syndrome) known to impair sleep Other
  21. Known alcohol or substance abuse
  22. Work or lifestyle potentially interfering with regular night-time sleep (e.g. shift workers)
  23. Previous desmopressin treatment for nocturia
  24. Psychiatric condition, mental incapacity or language barrier which, in the judgment of the investigator, would impair patient participation in the trial

Concomitant Medications

The following medications are permitted provided that the subject has been on a stable dose for the 3 months prior to the screening date (i.e. treatment has not been initiated or discontinued and there has been no change in dose):

  • Alpha-blockers: Cardura (doxazosin); Flomax (tamsulosin); Hytrin (terazosin); Uroxatral (alfuzosin)
  • 5 alpha-reductase inhibitors: Avodart (dutaseride); Proscar (finasteride)
  • Antispasmodic, anticholinergic, antimuscarinic therapy for overactive bladder: Detrol, Detrol LA (tolterodine); Ditropan, Ditropan XL (oxybutynin); Enablex (darifenacin); Levsin(hyoscyamine); Oxytrol transdermal (oxybutynin); Sanctura (trospium); Vesicare (solifenacin)
  • Sedative/hypnotic medications for sleep disorders
  • Selective serotonin and mixed norepinephrine/serotonin reuptake inhibitors: Celexa (citalopram); Cymbalta (duloxetine); Effexor (venlafaxine); Lexapro (escitalopram); Paxil(paroxetine); Prozac (fluoxetine); Zoloft (sertraline)
  • Chronic use of non-steroidal anti-inflammatory agents
  • Diabinese (chlorpropamide)
  • Carbamazepine (carbatrol/tegretol)
  • Amiodarone

The following medications are excluded:

  • Diuretics
  • Any other investigational drug within 30 days of screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477490

  Show 80 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00477490     History of Changes
Other Study ID Numbers: FE992026 CS29, ICH GCD
Study First Received: May 22, 2007
Last Updated: September 20, 2012
Health Authority: United States: Food and Drug Administration
Canada: Canadian Health Authority

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

ClinicalTrials.gov processed this record on November 27, 2014