DiabetesPhase 2NCT02412852
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
A Phase 2 study testing Sodium nitrite in people with Diabetes, run by TheraVasc Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Sodium nitrite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2015to 3 Apr 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Sodium nitrite, Placebo
- Keywords
- neuropathy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium nitriteDrug
Also called TV1001sr
Sustained release formulation of sodium nitrite
PlaceboDrug
Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One placebo tablet administered twice daily for 12 weeks. Receives: Drug: Placebo |
| 40 mg TV1001sr | Active comparator | One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily. Receives: Drug: Sodium nitrite |
| Placebo (2) | Placebo comparator | Two placebo tablets administered twice daily for 12 weeks. Receives: Drug: Placebo |
| 80 mg TV1001sr | Active comparator | Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily. Receives: Drug: Sodium nitrite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
Pharmacokinetics (Blood Levels of Nitrite)
Blood levels of nitrite will be assessed for 6 hours post-administration on the initial dosing visit.
Measured: 1 day
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
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.
Measured: 12 weeks
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
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.
Measured: Baseline (visit 1) and 12 weeks (visit 3)
Clinical Assessment of Pain. (Quantitative Sensory Testing)
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.
Measured: 12 weeks
Assessment of Diabetes. (HbA1C Levels)
HbA1C levels will be monitored at each visit to determine whether treatment reduces circulating glucose levels.
Measured: 12 weeks
Assessment of Blood Oxygenation. (Pulse Oximetry)
Pulse oximetry will be used at each visit to determine whether treatment improves oxygen levels in the blood.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study start28 Apr 2015
- Primary completion7 Dec 2015
- Study completion3 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- TheraVasc Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kettering Health Network
- Responsible party
- Sponsor
- Investigators
- Amol Soin, PhD, Principal investigator, Ohio Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412852
- Sponsor's protocol ID
- TheraVasc-TV1001-003
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2015
- Last updated
- 24 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD will only be available to the PI of the trial, summary information will be published and shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02412852
- Acronym / sponsor ID
- TheraVasc-TV1001-003
- Conditions
- Diabetes
- Keywords
- neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- TheraVasc Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kettering Health Network
- Study start
- 28 Apr 2015 (actual)
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOne placebo tablet administered twice daily for 12 weeks. |
| 40 mg TV1001sr | Active comparator | Drug: Sodium nitriteOne 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily. |
| Placebo (2) | Placebo comparator | Drug: PlaceboTwo placebo tablets administered twice daily for 12 weeks. |
| 80 mg TV1001sr | Active comparator | Drug: Sodium nitriteTwo 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium nitriteAlso: TV1001srSustained release formulation of sodium nitrite | Drug | 40 mg TV1001sr, 80 mg TV1001sr |
| PlaceboPlacebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added. | Drug | Placebo, Placebo (2) |
Primary outcome
Reporting of Adverse Events During 12 Week Study Period
Time frame: 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.
6 secondary outcomes
Pharmacokinetics (Blood Levels of Nitrite)
Time frame: 1 day
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Time frame: 12 weeks
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
Time frame: Baseline (visit 1) and 12 weeks (visit 3)
Clinical Assessment of Pain. (Quantitative Sensory Testing)
Time frame: 12 weeks
Assessment of Diabetes. (HbA1C Levels)
Time frame: 12 weeks
Assessment of Blood Oxygenation. (Pulse Oximetry)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will only be available to the PI of the trial, summary information will be published and shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol Soin, PhD principal investigator
Ohio Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium nitrite in people with Diabetes, run by TheraVasc Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reporting of Adverse Events During 12 Week Study Period (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.