Trial Outcomes & Findings for A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain (NCT NCT02412852)
NCT ID: NCT02412852
Last Updated: 2020-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-04-24
Participant Flow
Participant milestones
| Measure |
Placebo
One placebo tablet administered twice daily for 12 weeks.
Placebo: Placebo tablets
|
40 mg TV1001sr
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Sodium nitrite: Sustained release formulation of sodium nitrite
|
Placebo (2)
Two placebo tablets administered twice daily for 12 weeks.
Placebo: Placebo tablets
|
80 mg TV1001sr
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Sodium nitrite: Sustained release formulation of sodium nitrite
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
8
|
5
|
9
|
|
Overall Study
COMPLETED
|
4
|
7
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
One placebo tablet administered twice daily for 12 weeks.
Placebo: Placebo tablets
|
40 mg TV1001sr
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Sodium nitrite: Sustained release formulation of sodium nitrite
|
Placebo (2)
Two placebo tablets administered twice daily for 12 weeks.
Placebo: Placebo tablets
|
80 mg TV1001sr
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Sodium nitrite: Sustained release formulation of sodium nitrite
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
One placebo tablet administered twice daily for 12 weeks.
Placebo: Placebo tablets
|
40 mg TV1001sr
n=8 Participants
One 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Sodium nitrite: Sustained release formulation of sodium nitrite
|
Placebo (2)
n=5 Participants
Two placebo tablets administered twice daily for 12 weeks.
Placebo: Placebo tablets
|
80 mg TV1001sr
n=9 Participants
Two 40 mg enteric coated sustained release, sodium nitrite tablets administered twice daily.
Sodium nitrite: Sustained release formulation of sodium nitrite
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
26 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Randomized population including dropouts.
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.
Outcome measures
| Measure |
Combined Placebo
n=9 Participants
A combination of the once/day and twice/day placebo groups.
|
40 mg TV1001sr
n=8 Participants
Treatment twice daily with 40 mg sustained release sodium nitrite
|
80 mg TV1001sr
n=9 Participants
Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
|
|---|---|---|---|
|
Reporting of Adverse Events During 12 Week Study Period
Subjects reporting at least one Adverse Event
|
9 Adverse Events
|
8 Adverse Events
|
7 Adverse Events
|
|
Reporting of Adverse Events During 12 Week Study Period
Total Adverse Events reported in each cohort
|
29 Adverse Events
|
23 Adverse Events
|
24 Adverse Events
|
SECONDARY outcome
Timeframe: 1 dayPopulation: All subjects who were randomized.
Blood levels of nitrite will be assessed for 6 hours post-administration on the initial dosing visit.
Outcome measures
| Measure |
Combined Placebo
n=9 Participants
A combination of the once/day and twice/day placebo groups.
|
40 mg TV1001sr
n=8 Participants
Treatment twice daily with 40 mg sustained release sodium nitrite
|
80 mg TV1001sr
n=9 Participants
Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
|
|---|---|---|---|
|
Pharmacokinetics (Blood Levels of Nitrite)
|
1399 ng/ml
Standard Deviation 47
|
9699 ng/ml
Standard Deviation 10199
|
9905 ng/ml
Standard Deviation 12383
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analyzed only those subjects who completed 12 weeks of testing.
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.
Outcome measures
| Measure |
Combined Placebo
n=9 Participants
A combination of the once/day and twice/day placebo groups.
|
40 mg TV1001sr
n=7 Participants
Treatment twice daily with 40 mg sustained release sodium nitrite
|
80 mg TV1001sr
n=8 Participants
Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
|
|---|---|---|---|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using Cymbalta
|
1 Participants
|
1 Participants
|
2 Participants
|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using Vicodin
|
2 Participants
|
2 Participants
|
1 Participants
|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using any medicine to treat pain
|
9 Participants
|
7 Participants
|
8 Participants
|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using Gabapentin
|
6 Participants
|
6 Participants
|
3 Participants
|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using Lyrica
|
4 Participants
|
4 Participants
|
4 Participants
|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using Morphine
|
2 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using Tramadol
|
1 Participants
|
3 Participants
|
3 Participants
|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using Flexeril
|
1 Participants
|
0 Participants
|
2 Participants
|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using Naproxen
|
1 Participants
|
3 Participants
|
0 Participants
|
|
The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.
Subjects using Percocet
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (visit 1) and 12 weeks (visit 3)Population: NPS is a sum of total scores, McGill and BPI an average of the scores for each question.
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.
Outcome measures
| Measure |
Combined Placebo
n=9 Participants
A combination of the once/day and twice/day placebo groups.
|
40 mg TV1001sr
n=7 Participants
Treatment twice daily with 40 mg sustained release sodium nitrite
|
80 mg TV1001sr
n=8 Participants
Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
|
|---|---|---|---|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
NPSI: Total-V1
|
47.4 units on a scale
Interval 7.0 to 75.0
|
34.7 units on a scale
Interval 18.0 to 80.0
|
56.0 units on a scale
Interval 21.0 to 83.0
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
NPSI: Total-V3
|
43.4 units on a scale
Interval 9.0 to 81.0
|
30.0 units on a scale
Interval 0.0 to 76.0
|
46.0 units on a scale
Interval 6.0 to 73.0
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
BPI: Severity Score-V1
|
5.1 units on a scale
Interval 1.25 to 7.5
|
4.3 units on a scale
Interval 1.25 to 8.5
|
5.9 units on a scale
Interval 2.5 to 9.3
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
BPI: Severity Score-V3
|
4.8 units on a scale
Interval 1.5 to 7.8
|
3.8 units on a scale
Interval 0.8 to 8.8
|
5.1 units on a scale
Interval 2.0 to 8.3
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
BPI: Interferrence-V1
|
5.0 units on a scale
Interval 0.0 to 9.7
|
4.4 units on a scale
Interval 0.7 to 7.9
|
6.4 units on a scale
Interval 2.0 to 8.5
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
BPI: Interferrence-V3
|
4.3 units on a scale
Interval 0.0 to 10.0
|
4.2 units on a scale
Interval 1.1 to 8.6
|
5.7 units on a scale
Interval 3.1 to 8.9
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
McGill: Total-V1
|
5.1 units on a scale
Interval 1.1 to 9.1
|
3.9 units on a scale
Interval 1.8 to 7.6
|
4.8 units on a scale
Interval 1.7 to 7.9
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
McGill: Total-V3
|
3.6 units on a scale
Interval 0.4 to 7.5
|
2.5 units on a scale
Interval 0.5 to 7.2
|
4.6 units on a scale
Interval 0.5 to 7.0
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
McGill: Continuous-V1
|
5.0 units on a scale
Interval 1.0 to 9.0
|
3.7 units on a scale
Interval 0.9 to 7.2
|
4.4 units on a scale
Interval 0.5 to 8.0
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
McGill: Continuous-V3
|
3.2 units on a scale
Interval 0.0 to 6.6
|
1.9 units on a scale
Interval 0.0 to 5.8
|
4.3 units on a scale
Interval 0.7 to 7.5
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
McGill: Intermittent-V1
|
6.0 units on a scale
Interval 0.0 to 9.7
|
4.6 units on a scale
Interval 2.3 to 8.5
|
5.9 units on a scale
Interval 0.3 to 8.0
|
|
Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.
McGill: Intermittent-V3
|
4.1 units on a scale
Interval 0.0 to 9.2
|
2.8 units on a scale
Interval 0.0 to 8.3
|
5.3 units on a scale
Interval 0.0 to 7.3
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Analyzed only the subjects that completed 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.
Outcome measures
| Measure |
Combined Placebo
n=9 Participants
A combination of the once/day and twice/day placebo groups.
|
40 mg TV1001sr
n=7 Participants
Treatment twice daily with 40 mg sustained release sodium nitrite
|
80 mg TV1001sr
n=8 Participants
Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
|
|---|---|---|---|
|
Clinical Assessment of Pain. (Quantitative Sensory Testing)
Nerve Conductance: Baseline
|
3.9 meters per second
Standard Deviation 1.4
|
3.4 meters per second
Standard Deviation 0.7
|
6.0 meters per second
Standard Deviation 2.9
|
|
Clinical Assessment of Pain. (Quantitative Sensory Testing)
Nerve Conductance: V2
|
4.3 meters per second
Standard Deviation 1.8
|
3.1 meters per second
Standard Deviation 0.9
|
5.2 meters per second
Standard Deviation 3.0
|
|
Clinical Assessment of Pain. (Quantitative Sensory Testing)
Nerve Conductance: V3
|
3.5 meters per second
Standard Deviation 1.2
|
3.2 meters per second
Standard Deviation 0.6
|
4.2 meters per second
Standard Deviation 1.5
|
|
Clinical Assessment of Pain. (Quantitative Sensory Testing)
Nerve Velocity: Baseline
|
44.7 meters per second
Standard Deviation 6.5
|
41.1 meters per second
Standard Deviation 4.3
|
39.4 meters per second
Standard Deviation 8.2
|
|
Clinical Assessment of Pain. (Quantitative Sensory Testing)
Nerve Velocity: V2
|
40.1 meters per second
Standard Deviation 5.3
|
39.3 meters per second
Standard Deviation 7.8
|
42.3 meters per second
Standard Deviation 10.7
|
|
Clinical Assessment of Pain. (Quantitative Sensory Testing)
Nerve Velocity: V3
|
43.2 meters per second
Standard Deviation 6.4
|
37.7 meters per second
Standard Deviation 3.2
|
46.8 meters per second
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: HbA1c blood levels were analyzed at baseline, V2 and V3
HbA1C levels will be monitored at each visit to determine whether treatment reduces circulating glucose levels.
Outcome measures
| Measure |
Combined Placebo
n=9 Participants
A combination of the once/day and twice/day placebo groups.
|
40 mg TV1001sr
n=7 Participants
Treatment twice daily with 40 mg sustained release sodium nitrite
|
80 mg TV1001sr
n=8 Participants
Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
|
|---|---|---|---|
|
Assessment of Diabetes. (HbA1C Levels)
Baseline
|
7.7 percentage of glycosylated hemoglobin
Standard Deviation 1.4
|
7.7 percentage of glycosylated hemoglobin
Standard Deviation 1.2
|
8.5 percentage of glycosylated hemoglobin
Standard Deviation 2.4
|
|
Assessment of Diabetes. (HbA1C Levels)
V2
|
7.3 percentage of glycosylated hemoglobin
Standard Deviation 1.2
|
7.4 percentage of glycosylated hemoglobin
Standard Deviation 0.9
|
7.9 percentage of glycosylated hemoglobin
Standard Deviation 1.8
|
|
Assessment of Diabetes. (HbA1C Levels)
V3
|
7.6 percentage of glycosylated hemoglobin
Standard Deviation 2.0
|
7.7 percentage of glycosylated hemoglobin
Standard Deviation 1.6
|
8.2 percentage of glycosylated hemoglobin
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Oxygen saturation was measured at baseline, V2 and V3.
Pulse oximetry will be used at each visit to determine whether treatment improves oxygen levels in the blood.
Outcome measures
| Measure |
Combined Placebo
n=9 Participants
A combination of the once/day and twice/day placebo groups.
|
40 mg TV1001sr
n=7 Participants
Treatment twice daily with 40 mg sustained release sodium nitrite
|
80 mg TV1001sr
n=8 Participants
Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
|
|---|---|---|---|
|
Assessment of Blood Oxygenation. (Pulse Oximetry)
Baseline
|
95.7 % Oxygenation
Standard Deviation 2.6
|
95.6 % Oxygenation
Standard Deviation 2.3
|
96.3 % Oxygenation
Standard Deviation 1.7
|
|
Assessment of Blood Oxygenation. (Pulse Oximetry)
V2
|
96.0 % Oxygenation
Standard Deviation 3.0
|
96.4 % Oxygenation
Standard Deviation 2.2
|
95.3 % Oxygenation
Standard Deviation 3.2
|
|
Assessment of Blood Oxygenation. (Pulse Oximetry)
V3
|
94.2 % Oxygenation
Standard Deviation 2.8
|
96.0 % Oxygenation
Standard Deviation 2.4
|
95.1 % Oxygenation
Standard Deviation 2.4
|
Adverse Events
Combined Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
40 mg TV1001sr
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
80 mg TV1001sr
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combined Placebo
n=9 participants at risk
A combination of the once/day and twice/day placebo groups.
|
40 mg TV1001sr
n=8 participants at risk
Treatment twice daily with 40 mg sustained release sodium nitrite
|
80 mg TV1001sr
n=9 participants at risk；n=8 participants at risk
Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hyponatremia
|
0.00%
0/9 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
12.5%
1/8 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
12.5%
1/8 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
12.5%
1/8 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/8 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Cardiac disorders
Chest pains
|
11.1%
1/9 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/8 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/8 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Infections and infestations
Febrile illness
|
0.00%
0/9 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/8 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
12.5%
1/8 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
Other adverse events
| Measure |
Combined Placebo
n=9 participants at risk
A combination of the once/day and twice/day placebo groups.
|
40 mg TV1001sr
n=8 participants at risk
Treatment twice daily with 40 mg sustained release sodium nitrite
|
80 mg TV1001sr
n=9 participants at risk；n=8 participants at risk
Treatment with 80 mg (2 x 40 mg tablets) twice daily with sustained release sodium nitrite
|
|---|---|---|---|
|
Nervous system disorders
Headaches
|
22.2%
2/9 • Number of events 2 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/8 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
22.2%
2/9 • Number of events 2 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 2 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
25.0%
2/8 • Number of events 2 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
22.2%
2/9 • Number of events 2 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Renal and urinary disorders
Urinary Disorders
|
11.1%
1/9 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
37.5%
3/8 • Number of events 3 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
11.1%
1/9 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Gastrointestinal disorders
Ulcers
|
0.00%
0/9 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
12.5%
1/8 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
11.1%
1/9 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
General disorders
Swelling
|
44.4%
4/9 • Number of events 4 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/8 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
11.1%
1/9 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
25.0%
2/8 • Number of events 2 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/9 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Nervous system disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
12.5%
1/8 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/9 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
General disorders
Dry Mouth
|
0.00%
0/9 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
12.5%
1/8 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
11.1%
1/9 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
12.5%
1/8 • Number of events 1 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/9 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
|
Nervous system disorders
Numbness
|
22.2%
2/9 • Number of events 2 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/8 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
0.00%
0/9 • 9 months
Asked subjects at each phone call and visit to report any adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place