Clinical trial NCT02412852: A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Keywords: neuropathy
Lead sponsor: TheraVasc Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kettering Health Network
First posted: 2015-04-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reporting of Adverse Events During 12 Week Study Period
timeFrame: 12 weeks
Secondary outcomes:
measure: Pharmacokinetics (Blood Levels of Nitrite)
timeFrame: 1 day
measure: The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
timeFrame: 12 weeks
measure: Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
timeFrame: Baseline (visit 1) and 12 weeks (visit 3)
measure: Clinical Assessment of Pain. (Quantitative Sensory Testing)
timeFrame: 12 weeks
measure: Assessment of Diabetes. (HbA1C Levels)
timeFrame: 12 weeks
measure: Assessment of Blood Oxygenation. (Pulse Oximetry)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Centerville
country: United States
facility: Ohio Pain Clinic
state: Ohio
Study officials:
affiliation: Ohio Pain Clinic
name: Amol Soin, PhD
role: PRINCIPAL_INVESTIGATOR
References: