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Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain

11. April 2019 aktualisiert von: Pfizer

A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo

Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Methodology to assess reproducibility and sensitivity of quantitative sensory testing

Studientyp

Interventionell

Einschreibung (Tatsächlich)

31

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • Belgien
      • Bruxelles, Belgien, 1070
        • Pfizer Investigational Site
  • Frankreich
      • Boulogne Billancourt, Frankreich, 92100
        • Pfizer Investigational Site
  • Vereinigtes Königreich
      • Liverpool, Vereinigtes Königreich, L9 7AL
        • Pfizer Investigational Site
      • London, Vereinigtes Königreich, SW10 9NH
        • Pfizer Investigational Site
  • Österreich
      • Vienna, Österreich, A-1090
        • Pfizer Investigational Site

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:

  • Neuropathic pain of peripheral origin demonstrating spontaneous ongoing pain and dynamic mechanical allodynia to brush stimuli.
  • A present pain intensity score of 4 or more (out of 10) for spontaneous ongoing pain and brush-evoked allodynia at the skin area at screen.
  • Stable analgesic medication (excluding pregabalin) for a minimum of 1 month prior to the start of study.

Exclusion Criteria:

  • Patients who have undergone neurolytic or neurosurgical therapy.
  • Patients who have trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and traumatic spinal cord injuries), complex regional pain syndrome (Type I and II), and phantom limb pain.
  • Patients who have previously been treated with pregabalin.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Arzneimittel: Placebo
BID dosing for 28 days
Aktiver Komparator: Aktives Medikament
Arzneimittel: Pregabalin
Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days. Dose reduced for renally impaired patients

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7
Zeitfenster: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7
Zeitfenster: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Zeitfenster: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Zeitfenster: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Zeitfenster: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Zeitfenster: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7
Zeitfenster: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7
Zeitfenster: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7
Zeitfenster: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to "How intense is your pain today?"
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7
Zeitfenster: Week 4 (Visits 4 and 7) of each period
NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.
Week 4 (Visits 4 and 7) of each period

Mitarbeiter und Ermittler

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

Sponsor

Pfizer

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.

Nützliche Links

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. Dezember 2006

Primärer Abschluss (Tatsächlich)

1. September 2009

Studienabschluss (Tatsächlich)

1. September 2009

Studienanmeldedaten

Zuerst eingereicht

4. Mai 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Mai 2010

Zuerst gepostet (Schätzen)

5. Mai 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. April 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. April 2019

Zuletzt verifiziert

1. April 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A9011015

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 .

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