Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

29. September 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

799

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: 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).
Arzneimittel: 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).
Arzneimittel: 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
Andere Namen:
  • FE992026
  • Nocturin®
  • Minirin® Schmelze
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).
Arzneimittel: 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
Andere Namen:
  • FE992026
  • Nocturin®
  • Minirin® Schmelze
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).
Arzneimittel: 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
Andere Namen:
  • FE992026
  • Nocturin®
  • Minirin® Schmelze
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).
Arzneimittel: 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
Andere Namen:
  • FE992026
  • Nocturin®
  • Minirin® Schmelze

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Zeitfenster: - 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
Zeitfenster: - 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
Zeitfenster: - 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
Zeitfenster: - 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
Zeitfenster: - 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
Zeitfenster: - 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
Zeitfenster: - 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
Zeitfenster: - 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
Zeitfenster: - 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
Zeitfenster: - 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ferring Pharmaceuticals

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2007

Primärer Abschluss (Tatsächlich)

1. Februar 2008

Studienabschluss (Tatsächlich)

1. Februar 2008

Studienanmeldedaten

Zuerst eingereicht

22. Mai 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Mai 2007

Zuerst gepostet (Schätzen)

23. Mai 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

1. November 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. September 2015

Zuletzt verifiziert

1. September 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FE992026 CS29

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren