PainPhase 1NCT05893160
Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty
A Phase 1 study testing JAN101 SR in people with Pain, run by University of Alabama at Birmingham.
Trial summary
This study will determine whether a drug called sodium nitrite helps improve pain and post-operative recovery associated with knee replacement surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- JAN101 SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Aug 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male and female individuals aged 18-70
- Ambulatory with knee pain for greater than 6 months prior to surgery, and willing and able to comply with all study requirements will be considered eligible.
Who cannot join
- Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 120 mmHg);
- BMI greater than 45 kg/m2;
- Active smoker or stopped smoking within 6 months of enrollment;
- Active local or systemic malignancy, such as lung cancer or leukemia;
- Cardiovascular disease resulting in dyspnea at rest;
- Peripheral neurovascular disease;
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- Anemia;
- Hematological disease (eg, coagulopathy, sickle cell disease/anemia);
- Hemoglobin variant;
- Glucose-6-phosphate dehydrogenase deficiency;
- Methemoglobin reductase deficiency;
- Known sensitivity to nitrites;
- Liver disease;
- Use of phosphodiesterase type 5 inhibitors;
- Use of sildenafil (Viagra);
- Systemic treatment with antibiotics, immunosuppressants including corticosteroids, medications for migraine, allopurinol, tricyclic antidepressants, antihistamines, and/or nitrates currently or in the last month;
- Use of nitrovasodilators (e.g. GTN) within the last month;
- Use of protein pump inhibitors within the last month;
- History of substance abuse;
- Recent surgery or hospitalization (within last 6 months);
- Inability to swallow a pill;
- Failure to provide full consent;
- Involvement with a worker's compensation, personal injury, or other legal matter related to participant health.
About this study
Official title: Effects of Sustained-release Oral Sodium Nitrite Supplementation on Pain-related Outcomes and Peri- and Postoperative Physiology in People Undergoing Unilateral All-component Revision Total Knee Arthroplasty
This study will determine whether a drug called sodium nitrite helps improve pain and post-operative recovery associated with knee replacement surgery.
Read the detailed description
The goal of this study is to examine the potential for oral sodium nitrite supplementation to reduce postoperative pain and inflammation and improve functional recovery in individuals undergoing unilateral revision total knee replacement. A sustained release formulation of sodium nitrite (40 mg) administered twice daily will be compared with placebo for a 30-day treatment period. Primary objectives are to evaluate pain and markers of functional improvement.
- Conditions
- Pain
- Being tested
- JAN101 SR, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAN101 SRDrug
Also called Sodium Nitrite SR
The dosage form of JAN101 to be used in clinical investigations is a sustained release (SR) tablet containing Sodium Nitrite drug substance.
PlaceboOther
Inert placebo formulation
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention | Experimental | The intervention group will receive sodium nitrite SR (40 mg b.i.d. for 30 days) Receives: Drug: JAN101 SR |
| Placebo | Placebo comparator | The comparison group will receive an inert placebo on the same schedule as the intervention group Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Requirements
Patients
Measured: 30 days
Short-form McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ is a validated test for the measurement of pain. The measure is calculated by summing the point values for responses to 15 questions. Questions 1-11 deal with the sensory dimension of pain (i.e., the quality of the pain). Questions 12-15 deal with the affective dimension of pain (i.e., how the pain affects you). Subscores for the sensory and affective dimensions are calculated, in addition to a total McGill Pain Score. In addition, there is a visual analogue scale for pain and a final question about pain intensity. Higher scores generally correspond to a worse subjective experience of pain.
Measured: 30 days
Brief Pain Inventory (BPI) short form
The BPI is a questionnaire used to assess the severity of pain (intensity) and its impact on functioning (interference). It uses a 0-10 numeric rating scale for item rating and has no scoring algorithm. Pain severity can be measured as the arithmetic mean of the four severity items, with a lower score indicating less pain. Pain interference can be measured from arithmetic mean of the seven interference items, with a lower score indicating less interference.
Measured: 30 days
Pain ratings
Ratings of pain intensity (PI) and pain unpleasantness (PU) will be obtained. A description of the difference between PI (ie, "how strong the pain feels") and PU (ie, "how unpleasant or disturbing the pain is for you") will be read to all participants. Following this, PI and PU will be assessed by asking participants for verbal self-reports on a 0-100 scale, with 0 = "No pain" or "Not at all unpleasant" and 100 = "Pain as intense as I can imagine" or "Pain as unpleasant as I can imagine". Numeric rating scales of PI and PU have demonstrated validity through their ability to detect treatment effects, as well as their strong association with other measures of sensory and affective components of pain.
Measured: 30 days
Quality of Recovery (QoR-15) questionnaire
The QoR-15 scale is a measurement of the quality of recovery from surgery and anesthesia measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery.
Measured: 30 days
Physical function
Performance-based measure of physical function will be obtained using a goniometer to measure range of motion (ROM), in degrees from 0-180, at the knee joints. A lower numeric ROM indicates worse physical function.
Measured: 30 days
Leg girth measurement
Girth measurements of both legs will be made while participants are in a reclined position. Knee joint circumference will be measured (in cm), and thigh circumference will be measured (in cm) at 5 cm and 10 cm above the kneecap while thigh muscles are contracted. Measurements will be used to calculate a Limb Symmetry Index ([circumference of injured leg / circumference of uninjured leg] * 100).
Measured: 30 days
White blood cell count
Blood will be drawn for the measurement of white blood cell (WBC) count in # of WBCs per microliter.
Measured: 30 days
Immune cell markers
CD11b/CD18 is a member of the leukocyte integrin family of heterodimeric adhesion molecules expressed on hematopoietic cells and are regarded as immune cell markers. Blood content of CD11b/CD18 expressing cells will be measured using flow cytometry with relative staining and optical density.
Measured: 30 days
Blood markers v1
Soluble P-selectin, F2-isoprostanes, protein carbonyls, tumor necrosis factor (TNF) alpha, CC chemokine ligand 2 (CCL2), protaglandin E2 (PGE2), and pentraxin 3 (PTX3) will be measured in blood plasma as indices of infection, oxidative stress, and inflammation. They will be quantified in units of pg/ml, where lower levels indicate less infection, oxidative stress, and inflammation.
Measured: 30 days
Blood markers v2
8-OH-deoxyguanine, nitrate, and nitrite will be measured in blood plasma as indices of oxidative damage and nitric oxide homoeostasis. They will be quantified in micromolar (uM) concentration, where lower levels indicate less oxidative damage.
Measured: 30 days
Timed-Up-and-Go test
This is a test for measuring the functional mobility. Participants will be timed during rising from an armchair, walking 3 meters, turning around, walking back, and sitting down again. Participants will be allowed to use the armrests and will be wearing their shoes.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jun 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Why it stopped: Study withdran per PI's request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer DeBerry, University of Alabama at Birmingham
- Investigators
- Jennifer DeBerry, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893160
- Sponsor's protocol ID
- IRB-300010657
- Other IDs
- UAB
- Status last verified
- Jun 2025
- First submitted
- 12 Apr 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sustained-release Oral Sodium Nitrite Supplementation on Pain-related Outcomes and Peri- and Postoperative Physiology in People Undergoing Unilateral All-component Revision Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05893160
- Acronym / sponsor ID
- IRB-300010657
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdran per PI's request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether a drug called sodium nitrite helps improve pain and post-operative recovery associated with knee replacement surgery.
Detailed description
The goal of this study is to examine the potential for oral sodium nitrite supplementation to reduce postoperative pain and inflammation and improve functional recovery in individuals undergoing unilateral revision total knee replacement. A sustained release formulation of sodium nitrite (40 mg) administered twice daily will be compared with placebo for a 30-day treatment period. Primary objectives are to evaluate pain and markers of functional improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention | Experimental | Drug: JAN101 SRThe intervention group will receive sodium nitrite SR (40 mg b.i.d. for 30 days) |
| Placebo | Placebo comparator | Other: PlaceboThe comparison group will receive an inert placebo on the same schedule as the intervention group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female individuals aged 18-70
- Ambulatory with knee pain for greater than 6 months prior to surgery, and willing and able to comply with all study requirements will be considered eligible.
Key exclusion criteria (23 listed)
- Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 120 mmHg);
- BMI greater than 45 kg/m2;
- Active smoker or stopped smoking within 6 months of enrollment;
- Active local or systemic malignancy, such as lung cancer or leukemia;
- Cardiovascular disease resulting in dyspnea at rest;
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 |
|---|---|---|
| JAN101 SRAlso: Sodium Nitrite SRThe dosage form of JAN101 to be used in clinical investigations is a sustained release (SR) tablet containing Sodium Nitrite drug substance. | Drug | Experimental Intervention |
| PlaceboInert placebo formulation | Other | Placebo |
Primary outcome
Opioid Requirements
Time frame: 30 days
Patients
Short-form McGill Pain Questionnaire (SF-MPQ)
Time frame: 30 days
The SF-MPQ is a validated test for the measurement of pain. The measure is calculated by summing the point values for responses to 15 questions. Questions 1-11 deal with the sensory dimension of pain (i.e., the quality of the pain). Questions 12-15 deal with the affective dimension of pain (i.e., how the pain affects you). Subscores for the sensory and affective dimensions are calculated, in addition to a total McGill Pain Score. In addition, there is a visual analogue scale for pain and a final question about pain intensity. Higher scores generally correspond to a worse subjective experience of pain.
Brief Pain Inventory (BPI) short form
Time frame: 30 days
The BPI is a questionnaire used to assess the severity of pain (intensity) and its impact on functioning (interference). It uses a 0-10 numeric rating scale for item rating and has no scoring algorithm. Pain severity can be measured as the arithmetic mean of the four severity items, with a lower score indicating less pain. Pain interference can be measured from arithmetic mean of the seven interference items, with a lower score indicating less interference.
Pain ratings
Time frame: 30 days
Ratings of pain intensity (PI) and pain unpleasantness (PU) will be obtained. A description of the difference between PI (ie, "how strong the pain feels") and PU (ie, "how unpleasant or disturbing the pain is for you") will be read to all participants. Following this, PI and PU will be assessed by asking participants for verbal self-reports on a 0-100 scale, with 0 = "No pain" or "Not at all unpleasant" and 100 = "Pain as intense as I can imagine" or "Pain as unpleasant as I can imagine". Numeric rating scales of PI and PU have demonstrated validity through their ability to detect treatment effects, as well as their strong association with other measures of sensory and affective components of pain.
Quality of Recovery (QoR-15) questionnaire
Time frame: 30 days
The QoR-15 scale is a measurement of the quality of recovery from surgery and anesthesia measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery.
Physical function
Time frame: 30 days
Performance-based measure of physical function will be obtained using a goniometer to measure range of motion (ROM), in degrees from 0-180, at the knee joints. A lower numeric ROM indicates worse physical function.
Leg girth measurement
Time frame: 30 days
Girth measurements of both legs will be made while participants are in a reclined position. Knee joint circumference will be measured (in cm), and thigh circumference will be measured (in cm) at 5 cm and 10 cm above the kneecap while thigh muscles are contracted. Measurements will be used to calculate a Limb Symmetry Index ([circumference of injured leg / circumference of uninjured leg] * 100).
White blood cell count
Time frame: 30 days
Blood will be drawn for the measurement of white blood cell (WBC) count in # of WBCs per microliter.
Immune cell markers
Time frame: 30 days
CD11b/CD18 is a member of the leukocyte integrin family of heterodimeric adhesion molecules expressed on hematopoietic cells and are regarded as immune cell markers. Blood content of CD11b/CD18 expressing cells will be measured using flow cytometry with relative staining and optical density.
Blood markers v1
Time frame: 30 days
Soluble P-selectin, F2-isoprostanes, protein carbonyls, tumor necrosis factor (TNF) alpha, CC chemokine ligand 2 (CCL2), protaglandin E2 (PGE2), and pentraxin 3 (PTX3) will be measured in blood plasma as indices of infection, oxidative stress, and inflammation. They will be quantified in units of pg/ml, where lower levels indicate less infection, oxidative stress, and inflammation.
Blood markers v2
Time frame: 30 days
8-OH-deoxyguanine, nitrate, and nitrite will be measured in blood plasma as indices of oxidative damage and nitric oxide homoeostasis. They will be quantified in micromolar (uM) concentration, where lower levels indicate less oxidative damage.
Timed-Up-and-Go test
Time frame: 30 days
This is a test for measuring the functional mobility. Participants will be timed during rising from an armchair, walking 3 meters, turning around, walking back, and sitting down again. Participants will be allowed to use the armrests and will be wearing their shoes.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Jennifer DeBerry, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JAN101 SR in people with Pain, run by University of Alabama at Birmingham.
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 2 inclusion and 23 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: withdrawn, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Opioid Requirements (time frame: 30 days). The study lists 12 primary outcomes in all. 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 Jun 2025.