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Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29 września 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

799

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: 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).
Lek: Placebo
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Eksperymentalny: 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).
Lek: 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
Inne nazwy:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Eksperymentalny: 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).
Lek: 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
Inne nazwy:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Eksperymentalny: 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).
Lek: 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
Inne nazwy:
  • FE992026
  • Nocturin®
  • Minirin® Melt
Eksperymentalny: 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).
Lek: 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
Inne nazwy:
  • FE992026
  • Nocturin®
  • Minirin® Melt

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Ramy czasowe: - 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
Ramy czasowe: - 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: - 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ferring Pharmaceuticals

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 maja 2007

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2008

Ukończenie studiów (Rzeczywisty)

1 lutego 2008

Daty rejestracji na studia

Pierwszy przesłany

22 maja 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 maja 2007

Pierwszy wysłany (Oszacować)

23 maja 2007

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

1 listopada 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 września 2015

Ostatnia weryfikacja

1 września 2015

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • FE992026 CS29

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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