Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain

13 avril 2020 mis à jour par: TheraVasc Inc.

A Randomized, Double-blinded, Phase 2a Study to Assess the Safety and Pharmacokinetics of a Sustained Release Formulation of Sodium Nitrite (TV1001sr) in Patients With Diabetic Neuropathic Pain (DNP)

In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily. Primary endpoints will be safety and pharmacokinetics. Assessment of the study medications affects on pain following treatment will also be recorded.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This is a dose-ranging study to evaluate the safety, pharmacokinetics, and tolerability of multiple doses of an oral, sustained release formulation of sodium nitrite (TV1001sr) in subjects with DNP. The primary objective is to assess the safety and tolerability of multiple doses of twice daily 40 mg and 80 mg TV1001sr compared with placebo over a 12 week treatment period and the pharmacokinetics of the sustained release formulation of sodium nitrite. Secondary objectives are to evaluate the pharmacokinetics and markers of functional improvement including pain questionnaires, quantitative sensory testing and changes in markers of diabetes.

Type d'étude

Interventionnel

Inscription (Réel)

26

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

  • États-Unis
    • Ohio
      • Centerville, Ohio, États-Unis, 45458
        • Ohio Pain Clinic

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 et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Female subjects must be post-menopausal, sterilized or using suitable birth control
  • Diagnosis of diabetes (HbA1c > 6.0)
  • Diagnosis of diabetic peripheral neuropathy pain in feet
  • Presence of ongoing diabetic neuropathic for at least 3 months
  • A pain score of greater than or equal to 4 on the Numerical Pain Rating Scale at screening
  • Ability to provide written informed consent

Exclusion Criteria:

  • Patients with fibromyalgia or regional pain caused by lumbar or cervical compression
  • History or diagnosis of significant neurological disease
  • History and diagnosis of clinically significant psychiatric diseases
  • Serious liver disease
  • Poorly controlled diabetes
  • Hypersensitivity to sodium nitrite or related compounds
  • Life expectancy < 6 months
  • A chronic illness that may increase the risks associated with this study
  • Active malignancy requiring active anti-neoplastic therapy that will, in the opinion of the investigator, interfere with study treatment or participation
  • Pregnant or nursing women
  • Current diagnosis of alcohol or other substance abuse
  • Current use of sildenafil or other phosphodiesterase Type 5 Inhibitors
  • History of methemoglobinemia, (met-Hb ≥ 15%)
  • Subject is involved in litigation or receives worker's compensation
  • Inability to speak English

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: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: Placebo
One placebo tablet administered twice daily for 12 weeks.
Médicament: Placebo
Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
Comparateur actif: 40 mg TV1001sr
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Médicament: Sodium nitrite
Sustained release formulation of sodium nitrite
Autres noms:
  • TV1001sr
Comparateur placebo: Placebo (2)
Two placebo tablets administered twice daily for 12 weeks.
Médicament: Placebo
Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
Comparateur actif: 80 mg TV1001sr
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Médicament: Sodium nitrite
Sustained release formulation of sodium nitrite
Autres noms:
  • TV1001sr

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Reporting of Adverse Events During 12 Week Study Period
Délai: 12 weeks
The primary objective of this clinical study is to evaluate the safety and tolerability of multiple doses of twice daily 40mg and 80mg sustained release sodium nitrite compared with placebo over a 12 week treatment period. The following safety parameters will also be assessed: concomitant medication usage, physical examination, vital signs, Comprehensive Metabolic Panel, and complete blood count. Assessment of acute adverse events (i.e., drop in blood pressure, dizziness) after administration of each dose level. Counts are number of subjects reporting at least 1 Adverse Event. The total Adverse Events recorded in each cohort is also reported.
12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pharmacokinetics (Blood Levels of Nitrite)
Délai: 1 day
Blood levels of nitrite will be assessed for 6 hours post-administration on the initial dosing visit.
1 day
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Délai: 12 weeks
Daily patient reported use of analgesic or medications for neuropathic pain. The use of medications were recorded at the baseline visit and during both the intermediate and final visit for each subject. All subjects used at least one prescription pain medication, other than one subject in the 80-mg dose cohort who used only ibuprofen to control pain. Most subjects used more than one prescription pain medication. There was no change in use of pain medications during the trial period.
12 weeks
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
Délai: Baseline (visit 1) and 12 weeks (visit 3)
Subjects completed the Brief pain inventory (BPI), RAND 36 questionnaire, neuropathic pain symptom inventory (NPSI) and Short Form McGill Pain Questionnaire at each visit for these self-reported questionnaires. The BPI is a questionnaire that measures the patient's subjective perception of pain, its exacerbating and alleviating factors, and perceived effect on functional status; the NPSI is a questionnaire that measures the symptoms associated with neuropathic pain; the Short Form McGill Questionnaire subjectively assesses the patients perception of pain described by commonly used adjectives associated with pain. NPSI is average of 12 questions, range from 0 (no pain) to 120 (maximal pain); For BPI severity and interference, questions are scored from 0-10, then there average score for each subsection is calculated (the higher the score, the worse the response); Scores on McGill range from 0-10, lower associated for less pain, then averaged for each sub score and total score.
Baseline (visit 1) and 12 weeks (visit 3)
Clinical Assessment of Pain. (Quantitative Sensory Testing)
Délai: 12 weeks
Quantitative sensory testing (QST) was conducted at each visit to determine patients sensitivity to pain. QST was assessed using a quantitative nerve conductance machine where nerves in the distal extremity are subjected to electrical stimulation to determine the sensory threshold of the skin. Nerve conductance measures how fast an electrical impulse moves through the nerve, and nerve velocity measures the speed at which an electrical impulse moves down a neuronal pathway.
12 weeks
Assessment of Diabetes. (HbA1C Levels)
Délai: 12 weeks
HbA1C levels will be monitored at each visit to determine whether treatment reduces circulating glucose levels.
12 weeks
Assessment of Blood Oxygenation. (Pulse Oximetry)
Délai: 12 weeks
Pulse oximetry will be used at each visit to determine whether treatment improves oxygen levels in the blood.
12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

TheraVasc Inc.

Collaborateurs

Kettering Health Network

Les enquêteurs

  • Chercheur principal: Amol Soin, PhD, Ohio Pain Clinic

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 (Réel)

28 avril 2015

Achèvement primaire (Réel)

7 décembre 2015

Achèvement de l'étude (Réel)

3 avril 2017

Dates d'inscription aux études

Première soumission

1 avril 2015

Première soumission répondant aux critères de contrôle qualité

8 avril 2015

Première publication (Estimation)

9 avril 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 avril 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 avril 2020

Dernière vérification

1 avril 2020

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • TheraVasc-TV1001-003

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Description du régime IPD

IPD will only be available to the PI of the trial, summary information will be published and shared with other researchers.

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 Placebo

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Malta

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

S'abonner