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

NCT02412852 | Completed Phase 2 Results DMC

• 1 other identifier: TheraVasc-TV1001-003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

neuropathy

Outcome Measures

Primary Outcomes (1)

• Reporting of Adverse Events During 12 Week Study Period

  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

Secondary Outcomes (6)

• Pharmacokinetics (Blood Levels of Nitrite)

  1 day

• The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.

  12 weeks

• Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.

  Baseline (visit 1) and 12 weeks (visit 3)

• Clinical Assessment of Pain. (Quantitative Sensory Testing)

  12 weeks

• Assessment of Diabetes. (HbA1C Levels)

  12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

One placebo tablet administered twice daily for 12 weeks.

Drug: Placebo

40 mg TV1001sr

ACTIVE COMPARATOR

One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.

Drug: Sodium nitrite

Placebo (2)

PLACEBO COMPARATOR

Two placebo tablets administered twice daily for 12 weeks.

Drug: Placebo

80 mg TV1001sr

ACTIVE COMPARATOR

Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.

Drug: Sodium nitrite

Interventions

Sodium nitrite DRUG

Sustained release formulation of sodium nitrite

Also known as: TV1001sr

40 mg TV1001sr; 80 mg TV1001sr

Placebo DRUG

Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.

Placebo; Placebo (2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TheraVasc Inc.: lead
• Kettering Health Network: collaborator

Study Sites (1)

Ohio Pain Clinic

Centerville, Ohio, 45458, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitrites; Nitrous Acid; Nitrogen Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Tony Giordano
• Organization: TheraVasc Inc.

tgiordano@theravasc.com

3183493851

Study Officials

• Amol Soin, PhD

  Ohio Pain Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 9, 2015
• Study Start: April 28, 2015
• Primary Completion: December 7, 2015
• Study Completion: April 3, 2017
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)