- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00993018
A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy
9 mai 2016 mis à jour par: 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).
Aperçu de l'étude
Statut
Résilié
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
77
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Arkansas
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Jonesboro, Arkansas, États-Unis
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California
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Fresno, California, États-Unis
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La Jolla, California, États-Unis
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Long Beach, California, États-Unis
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Redondo Beach, California, États-Unis
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Tustin, California, États-Unis
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Walnut Creek, California, États-Unis
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Florida
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Bradenton, Florida, États-Unis
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Palm Beach Gardens, Florida, États-Unis
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Maryland
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Baltimore, Maryland, États-Unis
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New York
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Albany, New York, États-Unis
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Syracuse, New York, États-Unis
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North Carolina
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Winston Salem, North Carolina, États-Unis
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Winston-Salem, North Carolina, États-Unis
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Ohio
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Toledo, Ohio, États-Unis
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Oklahoma
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Tulsa, Oklahoma, États-Unis
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis
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South Carolina
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Greer, South Carolina, États-Unis
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Tennessee
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Tullahoma, Tennessee, États-Unis
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Texas
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Austin, Texas, États-Unis
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Houston, Texas, États-Unis
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Plano, Texas, États-Unis
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San Antonio, Texas, États-Unis
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Washington
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Renton, Washington, États-Unis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
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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.
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Expérimental: 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.
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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.
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Expérimental: 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.
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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.
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Comparateur placebo: Placebo
Placebo will be administered as a single, subcutaneous injection every 28 days for up to 52 weeks.
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Patients will receive single injection of matching placebo every 28 days for up to 52 weeks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Average pain intensity
Délai: Baseline to Week 13
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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.
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Baseline to Week 13
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Pain at its worst
Délai: Baseline to Week 13
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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.
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Baseline to Week 13
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Brief Pain Inventory
Délai: Up to Week 105
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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.
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Up to Week 105
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Neuropathic pain symptom inventory (NPSI)
Délai: Up to Week 105
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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.
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Up to Week 105
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Patient Global Impression of Change (PGIC)
Délai: Up to week 105
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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.
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Up to week 105
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Number of patients with adverse events
Délai: Up to week 105 and 26 weeks after the last dose of study medication
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Up to week 105 and 26 weeks after the last dose of study medication
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2009
Achèvement primaire (Réel)
1 juin 2011
Achèvement de l'étude (Réel)
1 juin 2011
Dates d'inscription aux études
Première soumission
8 octobre 2009
Première soumission répondant aux critères de contrôle qualité
8 octobre 2009
Première publication (Estimation)
9 octobre 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
3 juin 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 mai 2016
Dernière vérification
1 mai 2016
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR016438
- 42160443NPP2002 (Autre identifiant: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
- 2008-007676-13 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur JNJ-42160443 (1 mg)
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Johnson & Johnson Pharmaceutical Research & Development...RésiliéLombalgie | Lombalgie, récurrenteÉtats-Unis, Belgique, Canada, Pays-Bas
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Janssen Research & Development, LLCComplétéDouleur, Rayonnement | Douleur, Brûlure | Douleur, Écrasement | Douleur, Migratrice | Douleur, FractionnementÉtats-Unis, France, Espagne, Pologne, Le Portugal
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Johnson & Johnson Pharmaceutical Research & Development...RésiliéLa douleur | Mononeuropathies | Névralgie | Névralgie post-zostérienneÉtats-Unis, Espagne, Belgique, Pays-Bas
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Johnson & Johnson Pharmaceutical Research & Development...RésiliéMaladies urologiques | Maladies de la vessie urinaire | Cystite | Cystite interstitielleÉtats-Unis, Canada
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Johnson & Johnson Pharmaceutical Research & Development...RésiliéLa douleur | Arthrose | Douleur articulaire | Arthralgie | Arthrose, Genou | Arthrose, HancheÉtats-Unis, Pologne, Canada, Corée, République de
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Janssen Research & Development, LLCComplété
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Janssen-Cilag International NVComplété
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Janssen Research & Development, LLCComplété
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Janssen Research & Development, LLCComplété
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Janssen Pharmaceutical K.K.Complété