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Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia

6 giugno 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

9

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Austria
      • Wien, Austria, A-1010
        • Pfizer Investigational Site
    • A-3541
      • Senftenberg, A-3541, Austria
        • Pfizer Investigational Site
  • Germania
      • Schwerin, Germania, 19053
        • Pfizer Investigational Site
  • Stati Uniti
    • Florida
      • Leesburg, Florida, Stati Uniti, 34748
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40509
        • Pfizer Investigational Site
    • North Carolina
      • Raleigh, North Carolina, Stati Uniti, 27612
        • Pfizer Investigational Site
    • Pennsylvania
      • Jekintown, Pennsylvania, Stati Uniti, 19046
        • Pfizer Investigational Site
  • Sud Africa
    • Gauteng
      • Pretoria, Gauteng, Sud Africa, 0122
        • Pfizer Investigational Site
    • Western Cape
      • Paarl, Western Cape, Sud Africa, 7626
        • Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Pregabalin (300-600 mg/day; 150 mg/day starting dose)
Droga: pregabalin
Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Neuropathic Pain Symptom Inventory (NPSI) at All Visits.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2012

Completamento primario (Effettivo)

1 giugno 2013

Completamento dello studio (Effettivo)

1 giugno 2013

Date di iscrizione allo studio

Primo inviato

16 aprile 2012

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2012

Primo Inserito (Stima)

22 maggio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

8 luglio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 giugno 2014

Ultimo verificato

1 giugno 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A9001464

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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