A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
13 aprile 2020 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
26
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
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Ohio
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Centerville, Ohio, Stati Uniti, 45458
- Ohio Pain Clinic
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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:
- 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
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: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: Placebo
One placebo tablet administered twice daily for 12 weeks.
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Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
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Comparatore attivo: 40 mg TV1001sr
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
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Sustained release formulation of sodium nitrite
Altri nomi:
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Comparatore placebo: Placebo (2)
Two placebo tablets administered twice daily for 12 weeks.
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Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
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Comparatore attivo: 80 mg TV1001sr
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
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Sustained release formulation of sodium nitrite
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Reporting of Adverse Events During 12 Week Study Period
Lasso di tempo: 12 weeks
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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.
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12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pharmacokinetics (Blood Levels of Nitrite)
Lasso di tempo: 1 day
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Blood levels of nitrite will be assessed for 6 hours post-administration on the initial dosing visit.
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1 day
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The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Lasso di tempo: 12 weeks
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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.
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12 weeks
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Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
Lasso di tempo: Baseline (visit 1) and 12 weeks (visit 3)
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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.
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Baseline (visit 1) and 12 weeks (visit 3)
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Clinical Assessment of Pain. (Quantitative Sensory Testing)
Lasso di tempo: 12 weeks
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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.
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12 weeks
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Assessment of Diabetes. (HbA1C Levels)
Lasso di tempo: 12 weeks
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HbA1C levels will be monitored at each visit to determine whether treatment reduces circulating glucose levels.
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12 weeks
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Assessment of Blood Oxygenation. (Pulse Oximetry)
Lasso di tempo: 12 weeks
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Pulse oximetry will be used at each visit to determine whether treatment improves oxygen levels in the blood.
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12 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Amol Soin, PhD, Ohio Pain Clinic
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 (Effettivo)
28 aprile 2015
Completamento primario (Effettivo)
7 dicembre 2015
Completamento dello studio (Effettivo)
3 aprile 2017
Date di iscrizione allo studio
Primo inviato
1 aprile 2015
Primo inviato che soddisfa i criteri di controllo qualità
8 aprile 2015
Primo Inserito (Stima)
9 aprile 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 aprile 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 aprile 2020
Ultimo verificato
1 aprile 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- TheraVasc-TV1001-003
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Descrizione del piano IPD
IPD will only be available to the PI of the trial, summary information will be published and shared with other researchers.
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 .