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A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy

9 maggio 2016 aggiornato da: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Diabetic Painful Neuropathy, Followed by a Double-Blind Safety Extension and an Open-Label Safety Extension

The purpose of this study is to evaluate the analgesic efficacy, safety and tolerability of multiple doses of JNJ-42160443 when administered as a single, subcutaneous injection every 28 days to patients with diabetic painful neuropathy (a disease condition in diabetic patients that affects all peripheral nerves including pain fibers, motor neurons and the autonomic nervous system).

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double-blind (neither investigator nor the patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), dose-ranging study (study carried out at different doses) to evaluate the analgesic efficacy, safety, and tolerability of multiple doses of JNJ-42160443 in patients with neuropathic pain, followed by a double-blind safety extension and an open-label (all people know the identity of the intervention) safety extension. The study will consist of 5 sequential phases: 1) screening, 2) a 12-week double-blind efficacy, 3) a 40-week double-blind safety extension, 4) a 52-week open-label safety extension, and 5) a 26-week post-treatment/follow-up. After the screening phase, patient randomization will be stratified by current pain medication use (patients who are currently using or who are not currently using permitted pain medication). The planned doses for the double-blind efficacy phase and double blind safety extension phase are placebo, JNJ-42160443 1, 3, or 10 mg administered as a single, subcutaneous injection every 28 days. Safety assessment will include adverse events, injection site evaluations, clinical laboratory tests, electrocardiogram, vital signs, physical examinations, neurological examinations, and joint safety which will be monitored throughout the study. The total study duration (including all the 5 phases) will be approximately 131 weeks.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

77

Fase

  • Fase 2

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

  • Stati Uniti
    • Arkansas
      • Jonesboro, Arkansas, Stati Uniti
    • California
      • Fresno, California, Stati Uniti
      • La Jolla, California, Stati Uniti
      • Long Beach, California, Stati Uniti
      • Redondo Beach, California, Stati Uniti
      • Tustin, California, Stati Uniti
      • Walnut Creek, California, Stati Uniti
    • Florida
      • Bradenton, Florida, Stati Uniti
      • Palm Beach Gardens, Florida, Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti
    • New York
      • Albany, New York, Stati Uniti
      • Syracuse, New York, Stati Uniti
    • North Carolina
      • Winston Salem, North Carolina, Stati Uniti
      • Winston-Salem, North Carolina, Stati Uniti
    • Ohio
      • Toledo, Ohio, Stati Uniti
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti
    • South Carolina
      • Greer, South Carolina, Stati Uniti
    • Tennessee
      • Tullahoma, Tennessee, Stati Uniti
    • Texas
      • Austin, Texas, Stati Uniti
      • Houston, Texas, Stati Uniti
      • Plano, Texas, Stati Uniti
      • San Antonio, Texas, Stati Uniti
    • Washington
      • Renton, Washington, Stati Uniti

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

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Chronic neuropathic pain (pain persistent for greater than 6 months) that is moderate to severe in the opinion of the investigator
  • Currently taking neuropathic pain medication limited to maximal allowed doses according to guidelines provided, but are not adequately controlled by standard of care
  • Currently not taking neuropathic pain medications because they are intolerable to, or not willing to use, standard of care
  • Mean average pain intensity score of at least 5, but less than 10, over 7 consecutive days on an 11-point numerical rating scale
  • Pain due to bilateral peripheral neuropathy caused by type 1 or type 2 diabetes mellitus
  • Required to have stable glycemic control

Exclusion Criteria:

  • Patients with severe diabetic neuropathy defined by severe autonomic dysfunction or blood pressure instability Separate pain condition (e.g., joint osteoarthritis) that is more severe than their pain due to their diagnosis of Diabetic Peripheral Neuropathy
  • Patients with evidence of another neuropathic pain not under the study, such as pain resulting from post-traumatic neuralgia, post-surgical neuropathy, complex regional pain, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, Human Immunodeficiency Virus (HIV) infection
  • Major surgeries, trauma, and non-healing wounds/ulcers within 3 months prior to study medication
  • History of severe traumatic brain injury within the past 15 years
  • Other peripheral neuropathy, parasthesia or dyesthesia or previously diagnosed neurological condition causing these symptoms not related with diabetic painful neuropathy under study

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: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: JNJ-42160443 (1 mg)
JNJ-42160443 1 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Droga: JNJ-42160443 (1 mg)
JNJ-42160443 1 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Sperimentale: JNJ-42160443 (3 mg)
JNJ-42160443 3 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Droga: JNJ-42160443 (3 mg)
JNJ-42160443 3 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Sperimentale: JNJ-42160443 (10 mg)
JNJ-42160443 10 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Droga: JNJ-42160443 (10 mg)
JNJ-42160443 10 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
Comparatore placebo: Placebo
Placebo will be administered as a single, subcutaneous injection every 28 days for up to 52 weeks.
Droga: Placebo
Patients will receive single injection of matching placebo every 28 days for up to 52 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Average pain intensity
Lasso di tempo: Baseline to Week 13
The mean of the daily evening assessment of average pain intensity is measured by using 11-point numerical rating scale (NRS), where 0 = no pain and 10 = pain as bad as the patient can imagine.
Baseline to Week 13

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain at its worst
Lasso di tempo: Baseline to Week 13
The assessment of pain at its worst in the past 24 hours will be performed once daily, in the evening, using an 11-point numerical rating scale (NRS), where 0 = no pain and 10 = pain as bad as the patient can imagine.
Baseline to Week 13
Brief Pain Inventory
Lasso di tempo: Up to Week 105
The Brief Pain Inventory short form (BPI-SF) includes 4 items assessing pain intensity (pain intensity subscales) and 7 items assessing how much pain has interfered with daily activities (pain interference subscales). The intensity of pain is assessed with 4 items using an 11-point NRS from 0 = no pain to 10 = higher severity of pain. This assessment will be conducted on daily basis.
Up to Week 105
Neuropathic pain symptom inventory (NPSI)
Lasso di tempo: Up to Week 105
The NPSI contains 12 questions designed to evaluate the different symptoms of neuropathic pain. The questions make up the following 5 subscales: burning (superficial) spontaneous pain, pressing (deep) spontaneous pain, paroxysmal pain, evoked pain and paresthesia/dysesthesia. Subscale scores can be derived from averaging the scores from the item scores that make up the subscales, ranging from 0 to 10. A total intensity score is the sum of the subscale scores, ranging from 0 to 100. Higher scores indicate worse pain. This assessment will be conducted on daily basis.
Up to Week 105
Patient Global Impression of Change (PGIC)
Lasso di tempo: Up to week 105
The patient will be asked to rate their change in their neuropathic pain with the following responses: very much improved, much improved, minimally improved, not changed, minimally worse, much worse, or very much worse. This assessment will be conducted on daily basis.
Up to week 105
Number of patients with adverse events
Lasso di tempo: Up to week 105 and 26 weeks after the last dose of study medication
Up to week 105 and 26 weeks after the last dose of study medication

Collaboratori e investigatori

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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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 novembre 2009

Completamento primario (Effettivo)

1 giugno 2011

Completamento dello studio (Effettivo)

1 giugno 2011

Date di iscrizione allo studio

Primo inviato

8 ottobre 2009

Primo inviato che soddisfa i criteri di controllo qualità

8 ottobre 2009

Primo Inserito (Stima)

9 ottobre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

3 giugno 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR016438
  • 42160443NPP2002 (Altro identificatore: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
  • 2008-007676-13 (Numero EudraCT)

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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