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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29 de septiembre de 2015 actualizado por: Ferring Pharmaceuticals

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

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

799

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • British Columbia
      • Kelowna, British Columbia, Canadá, V1Y-2H4
        • Southern Interior Medical Center
      • Victoria, British Columbia, Canadá, V8T 5G1
        • Can-Med Clinical Research Inc.
      • Victoria, British Columbia, Canadá, V8V 3N1
        • Investigational site - Clinical Research
    • New Brunswick
      • Fredericton, New Brunswick, Canadá, E3B 5B8
        • Investigational site - Professional Corporation
    • Ontario
      • Barrie, Ontario, Canadá, L4M 7G1
        • The Male/Female Health and Reserach
      • Brantford, Ontario, Canadá, N3R 4N3
        • Brantford Urology Research
      • Guelph, Ontario, Canadá, N1H 5J1
        • Guelph Urology Associates
      • North Bay, Ontario, Canadá, P1B 4Z2
        • Investigational Site
      • Oakville, Ontario, Canadá, L6H 3P1
        • The Fe/Male Health Centres
      • Toronto, Ontario, Canadá, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35209
        • Radiant Research
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85251
        • Radiant Research
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72204
        • Arkansas Primary Care Clinic
    • California
      • Anaheim, California, Estados Unidos, 92801
        • Advanced Urology Medical Center
      • Beverly Hills, California, Estados Unidos, 90211
        • Impact Clinical Trials
      • Long Beach, California, Estados Unidos, 90806
        • Atlantic Urology Medical Group
      • Newport Beach, California, Estados Unidos, 92660
        • California Professional Research
      • San Diego, California, Estados Unidos, 92103
        • San Diego Uro-Research
      • Santa Rosa, California, Estados Unidos, 95404
        • Radiant Research
      • Tarzana, California, Estados Unidos, 91356
        • West Coast Clinical Research
      • Torrance, California, Estados Unidos, 90505
        • Western Clinical Research
    • Colorado
      • Denver, Colorado, Estados Unidos, 80218
        • Downtown Women's Health Care
      • Denver, Colorado, Estados Unidos, 80220
        • Genitourinary Surgical Consultants
      • Denver, Colorado, Estados Unidos, 80210
        • Urology Associates PC
    • Connecticut
      • Middlebury, Connecticut, Estados Unidos, 06762
        • Connecticut Clinical Research Center, LLC
    • Florida
      • Aventura, Florida, Estados Unidos, 33180
        • South Florida Medical Research
      • Clearwater, Florida, Estados Unidos, 33759
        • Women's Medical Research Group, LLC
      • Miami, Florida, Estados Unidos, 33145
        • Medsearch Professional Group
      • Plantation, Florida, Estados Unidos, 33324
        • Sunrise Medical Research
      • Stuart, Florida, Estados Unidos, 34996
        • Radiant Research
      • Tallahassee, Florida, Estados Unidos, 32308
        • Southeastern Research Group, Inc.
      • Tampa, Florida, Estados Unidos, 33607
        • Tampa Bay Urology
      • West Palm Beach, Florida, Estados Unidos, 33407
        • Radiant Research
    • Georgia
      • Columbus, Georgia, Estados Unidos, 31904
        • Southeastern Medical Research Institute
      • Dunwoody, Georgia, Estados Unidos, 30338
        • Investigational site - PC
    • Illinois
      • Peoria, Illinois, Estados Unidos, 61602
        • Accelovance
    • Kansas
      • Overland park, Kansas, Estados Unidos, 66202
        • Radiant Research, Kansas City
    • Louisiana
      • Metairie, Louisiana, Estados Unidos, 70006
        • Benchmark Research
      • Shreveport, Louisiana, Estados Unidos, 71106
        • Regional Urology, LLC
      • Shreveport, Louisiana, Estados Unidos, 71111
        • Pierremont Women's Clinic
    • Massachusetts
      • Springfield, Massachusetts, Estados Unidos, 01103
        • FutureCare Studies, Inc.
    • Missouri
      • St. Louis, Missouri, Estados Unidos, 63141
        • Radiant Research Inc.
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68510
        • Women's Clinic of Lincoln, P.C
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89109
        • Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, Estados Unidos, 08648
        • Lawrenceville Urology
      • Lawrenceville, New Jersey, Estados Unidos, 08648
        • AdvanceMed Research
      • Morristown, New Jersey, Estados Unidos, 07960
        • Morristown Urology
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87109
        • Urology Group of New Mexico, PC
    • New York
      • Albany, New York, Estados Unidos, 12206
        • Upstate Urology
      • Carmel, New York, Estados Unidos, 10512
        • Investigational site - Adult & Pediatric Urology
      • Garden City, New York, Estados Unidos, 11530
        • AccuMed Research Associates
      • New York, New York, Estados Unidos, 10016
        • University Urology Associates
      • Suffern, New York, Estados Unidos, 10901
        • Ferring Pharmaceutical Inc
    • North Carolina
      • Concord, North Carolina, Estados Unidos, 28025
        • Northeast Urology Research
      • Greensboro, North Carolina, Estados Unidos, 27401
        • PharmQuest
      • Wilmington, North Carolina, Estados Unidos, 28401
        • New Hanover Medical Research
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • Piedmont Medical Research Associates
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45249
        • Radiant Research
      • Mogadore, Ohio, Estados Unidos, 44260
        • Radiant Research - Akron
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, Estados Unidos, 19004
        • Urologic Consultants of SE PA
      • Philadelphia, Pennsylvania, Estados Unidos, 19115
        • Radiant Research
      • Philadelphia, Pennsylvania, Estados Unidos, 19114
        • Philadelphia Clinical Research, LLC
      • Reading, Pennsylvania, Estados Unidos, 19611
        • Advanced Clinical Concepts
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29605
        • University Medical Group
      • Greer, South Carolina, Estados Unidos, 29651
        • Radiant Research, Greer
      • Mt. Pleasant, South Carolina, Estados Unidos, 29464
        • Palmetto Medical Research
      • Myrtle Beach, South Carolina, Estados Unidos, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Kingsport, Tennessee, Estados Unidos, 37660
        • Holston Medical Group
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Corpus Christi, Texas, Estados Unidos, 78414
        • Advanced Research Associates
      • Dallas, Texas, Estados Unidos, 75231
        • Health Central Women's Care
      • Houston, Texas, Estados Unidos, 77024
        • Accelovance
      • Humble, Texas, Estados Unidos, 77338
        • Regional Medical Center and Diagnostic
      • San Antonio, Texas, Estados Unidos, 78229
        • Urology San Antonio Research, PA
      • San Antonio, Texas, Estados Unidos, 78228
        • Radiant Research San Antonio
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23235
        • Virginia Urology Center
      • Virginia Beach, Virginia, Estados Unidos, 23454
        • Urology of Virginia PC
    • Washington
      • Seattle, Washington, Estados Unidos, 98105
        • Women's Clinical Research Center
      • Seattle, Washington, Estados Unidos, 98166
        • Seattle Urology Research Center
      • Seattle, Washington, Estados Unidos, 98166
        • Investigational site - Medical Professional

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 frequency-volume chart during the screening period.

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, bladder ultrasound or catheterization should be performed to confirm the diagnosis.
  7. Current or past urologic malignancy (e.g., bladder cancer, prostate cancer).
  8. Clinical evidence of current genitourinary tract pathology that could interfere with voiding.
  9. History of 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 and estimated glomerular filtration rate (eGFR) >=60 mL/min.
  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).
  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

    Other

  20. Known alcohol or substance abuse
  21. Work or lifestyle potentially interfering with regular nighttime sleep (e.g., shift workers)
  22. Previous desmopressin treatment for nocturia.
  23. Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity or language barrier that, in the judgment of the investigator, could impair patient participation in the trial.
  24. Use of loop diuretics (furosemide, torsemide, ethacrynic acid). Other classes of diuretics (thiazides, triamterene, chlorthalidone, amiloride, indapamide) were permitted, either as monotherapy or combination therapy. Subjects using a diuretic were to be encouraged to take it in the morning, if medically feasible.
  25. Use of any other investigational drug within 30 days of screening.

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 (dutasteride); 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 nonsteroidal anti-inflammatory agents
  • Diabinese (chlorpropamide)
  • Carbamazepine (carbatrol/tegretol)
  • Amiodarone

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Participants took a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients were randomized to one of the other 4 treatment arms based on assignments predetermined at the initial randomization, to receive active desmopressin melt for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Droga: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Experimental: desmopressin melt 10 μg
Participants took desmopressin melt 10 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Droga: desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Otros nombres:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Experimental: desmopressin melt 25 μg
Participants took desmopressin melt 25 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Droga: desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Otros nombres:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Experimental: desmopressin melt 50 μg
Participants took desmopressin melt 50 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
Droga: desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Otros nombres:
  • FE992026
  • Nocturin®
  • 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 part 2 of the study for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Droga: desmopressin acetate
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Otros nombres:
  • FE992026
  • Nocturin®
  • Minirin® Melt

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries.

This was the first co-primary outcome.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.

This was the second co-primary outcome.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part II outcomes tested the durability of the effect observed in Part I. The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Part I baseline and prior to the Part II visit as recorded in participant diaries.
- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part II outcomes tested the durability of the effect observed in Part I. Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to Days 29, 57, 113 and 169 in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries.
- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part I: Change From Baseline in Total Reported Sleep Time at Week 4
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Total sleep time was recorded by participants in study diaries.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Initial period of undisturbed sleep was the time elapsed from first falling asleep until either first void or morning arising. Data were captured in patient diaries.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
The ICIQ-N is a self-administered questionnaire designed to assess the frequency and bother of daytime and nighttime urination. Subjects were asked to rate the degree of bother of daytime urination and nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower quality of life.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
The NQoL questionnaire is a self-administered questionnaire designed to assess the impact of nocturia on quality of life. It contains a sleep/energy domain (6 questions), a bother/concern domain (6 questions), and 1 global QoL question. The twelve core questions are scored on a 0 to 4 scale with higher numbers indicating a better quality of life. Domain summary scores were calculated by transforming the raw score into a 0-100 scale with higher numbers indicating a better quality of life.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
The PSQI is a self-administered 19-item questionnaire designed to assess sleep quality and disturbances. The global score ranges from 0 (better sleep quality) to 21 (worse sleep quality). Higher numbers indicate lower quality of life.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4
Periodo de tiempo: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
The SF-12v2 was used to measure the impact of nocturia and lack of sleep on general quality of life. The SF-12 consists of 12 questions. Data were analyzed using norm-based scoring and summarized along 2 dimensions: Physical Health Summary and Mental Health Summary. Each summary has a range from 0 (poor health) to 100 (highest level of health). Higher numbers indicate better quality of life.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I
Periodo de tiempo: Day 1 up to Week 4 (end of Part I)
A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.
Day 1 up to Week 4 (end of Part I)
Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II
Periodo de tiempo: Week 5 up to Day 169
A treatment-emergent adverse event (AE) was any AE occurring during the treatment period or a pretreatment AE that worsened in intensity during the treatment period. The treatment period was the period during which a subject received investigational medicinal product. If a subject discontinued the investigational medicinal product, the date of last dose was the last day of the treatment period.
Week 5 up to Day 169

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ferring Pharmaceuticals

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2007

Finalización primaria (Actual)

1 de febrero de 2008

Finalización del estudio (Actual)

1 de febrero de 2008

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2007

Primero enviado que cumplió con los criterios de control de calidad

22 de mayo de 2007

Publicado por primera vez (Estimar)

23 de mayo de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

1 de noviembre de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2015

Última verificación

1 de septiembre de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • FE992026 CS29

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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