- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01603394
Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
6. Juni 2014 aktualisiert von: Pfizer
A Phase 4 Multicenter, Open-Label, Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The study was stopped on 26 April 2013 due to feasibility issues (low enrollment) not safety.
The overall risk-benefit of Lyrica has not changed at all due to termination of this trial.
Only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
9
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
-
Schwerin, Deutschland, 19053
- Pfizer Investigational Site
-
-
-
-
Gauteng
-
Pretoria, Gauteng, Südafrika, 0122
- Pfizer Investigational Site
-
-
Western Cape
-
Paarl, Western Cape, Südafrika, 7626
- Pfizer Investigational Site
-
-
-
-
Florida
-
Leesburg, Florida, Vereinigte Staaten, 34748
- Pfizer Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, Vereinigte Staaten, 40509
- Pfizer Investigational Site
-
-
North Carolina
-
Raleigh, North Carolina, Vereinigte Staaten, 27612
- Pfizer Investigational Site
-
-
Pennsylvania
-
Jekintown, Pennsylvania, Vereinigte Staaten, 19046
- Pfizer Investigational Site
-
-
-
-
-
Wien, Österreich, A-1010
- Pfizer Investigational Site
-
-
A-3541
-
Senftenberg, A-3541, Österreich
- 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:
- Subjects must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
- At screening (V1) and baseline (V2), subjects must have a score of >=4 on the Numeric Rating Scale for Pain (1 week recall period).
- At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be >=4.
Exclusion Criteria:
- Subjects having other severe pain that may confound assessment or self evaluation of the pain due to PHN.
- Neurolytic or neurosurgical therapy for Postherpetic Neuralgia
- Skin conditions in the affected dermatome that could alter sensation.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Pregabalin (300-600 mg/day; 150 mg/day starting dose)
|
Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).
Zeitfenster: Baseline, Week 6
|
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).
A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
|
Baseline, Week 6
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Neuropathic Pain Symptom Inventory (NPSI) at All Visits.
Zeitfenster: All visits
|
NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]).
Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain.
Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100.
Higher score indicates a greater intensity of pain.
|
All visits
|
Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6.
Zeitfenster: Baseline, Week 6
|
To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline.
Then for each of the above phenotypes the distribution of the pregabalin responders (using 30% and 50%) were to be compared.
|
Baseline, Week 6
|
Patient Global Impression of Change (PGIC) at Week 6/Early Termination.
Zeitfenster: Week 6/Early Termination
|
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).
|
Week 6/Early Termination
|
Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6.
Zeitfenster: Baseline, Week 6
|
The daily pain diary consists of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain").
Participants describe their pain during the previous 24 hours by choosing the appropriate number between 0 and 10.
Self-assessment is performed daily at bedtime on a telephone via interactive voice response system (IVRS).
The endpoint mean pain score is defined as the mean of the last 7 daily diary pain ratings while taking study medication in the open-label phase.
Daily pain IVRS diaries were completed daily at bedtime from Visit 1 (Screening) through Visit 7/Early Termination.
Participants were asked to complete their first IVRS daily at bedtime on the morning after Visit 1.
|
Baseline, Week 6
|
Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6.
Zeitfenster: Baseline, Week 6
|
To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline.
|
Baseline, Week 6
|
Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination.
Zeitfenster: Screening, Visit 2 (Week 0) and Week 6/Early Termination
|
The PHQ-8 is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.
The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day).
The PHQ-8 is a validated subset of the PHQ-9, which comprises the first 8 items of the measure.
The GAD-7 is a 7-item questionnaire that assesses anxiety.
Participants respond as to how each item applies to them on a 4 point response scale.
The higher the score, the more severe the anxiety.
|
Screening, Visit 2 (Week 0) and Week 6/Early Termination
|
Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6.
Zeitfenster: Visit 2 (Week 0), Week 6
|
The Brief Pain Inventory-Short Form (BPI-sf) consists of 5 questions.
Questions 1, 2, 3, and 4 measure pain on an 11-point scale from 0 (no pain) to 10 (worst pain possible).
|
Visit 2 (Week 0), Week 6
|
Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6.
Zeitfenster: Visit 2 (Week 0), Week 6
|
The PCS is a 13-item self report instrument and requires a Grade 6 reading level and has been translated into 12 languages.
It instructs participants to reflect on past experience of pain and indicate their experience using a 5-point scale.
The PCS was designed for research on catastrophizing and pain experience.
Catastrophizing is associated with heightened pain and is "an exaggerated negative mental set brought to bear during actual or anticipated painful experience."
It is a multidimensional construct compromising elements of rumination, magnification, and helplessness and its factor structure has been replicated.
It has a total score and three subscale scores (score range of 0-52).
|
Visit 2 (Week 0), Week 6
|
Pain NRS Score; 1 Week Recall Period.
Zeitfenster: 1 Week
|
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).
A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
|
1 Week
|
Short Form 12v2 Health Survey (SF 12v2) at Visit 2 (Week 0), and Week 6/Early Termination.
Zeitfenster: Visit 2 (Week 0), and Week 6/Early Termination
|
The Short-Form 12 Health Survey (SF-12v2) is a self-administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week.
Higher scores indicate a better health-related quality of life.
|
Visit 2 (Week 0), and Week 6/Early Termination
|
Change From Baseline to End of the Study (Week 6) in the Daily Sleep Interference Diary (NRS) Mean Pain Score.
Zeitfenster: Baseline, Week 6
|
The pain-related sleep interference item rating scale is scored on an 11-point numeric rating scale (NRS-Sleep).
It is self-administered by the participant in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain).
Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.
|
Baseline, Week 6
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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.
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. Oktober 2012
Primärer Abschluss (Tatsächlich)
1. Juni 2013
Studienabschluss (Tatsächlich)
1. Juni 2013
Studienanmeldedaten
Zuerst eingereicht
16. April 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. Mai 2012
Zuerst gepostet (Schätzen)
22. Mai 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
8. Juli 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Juni 2014
Zuletzt verifiziert
1. Juni 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Schmerzen
- Neurologische Manifestationen
- Neuromuskuläre Erkrankungen
- Erkrankungen des peripheren Nervensystems
- Neuralgie
- Neuralgie, Postzosterschmerz
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Depressiva des zentralen Nervensystems
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Beruhigende Agenten
- Psychopharmaka
- Membrantransportmodulatoren
- Anti-Angst-Mittel
- Antikonvulsiva
- Calciumregulierende Hormone und Wirkstoffe
- Kalziumkanalblocker
- Pregabalin
Andere Studien-ID-Nummern
- A9001464
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 .
Klinische Studien zur pregabalin
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Abgeschlossen
-
Jiangsu HengRui Medicine Co., Ltd.UnbekanntPostherpetische NeuralgieChina
-
Hamilton Health Sciences CorporationMcMaster UniversityBeendet
-
EMSRekrutierungNeuropathischer SchmerzBrasilien
-
Janssen-Cilag Ltd.Abgeschlossen
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Abgeschlossen
-
University of British ColumbiaJuvenile Diabetes Research FoundationUnbekanntDiabetes Typ 1Kanada
-
The First Hospital of Jilin UniversityAbgeschlossenSchmerzen, postoperativ | Arthroplastik, Ersatz, Knie | Arthroplastik, Ersatz, HüfteChina
-
Ziauddin UniversityAbgeschlossenSchmerz, Nerv | BandscheibenvorfallPakistan
-
Hospital for Special Surgery, New YorkAbgeschlossenPrimäre totale KnieendoprothetikVereinigte Staaten