Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty

NCT ID: NCT05893160

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2028-08-01

Brief Summary

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Intervention

The intervention group will receive sodium nitrite SR (40 mg b.i.d. for 30 days)

Group Type: EXPERIMENTAL

JAN101 SR

Intervention Type: DRUG

The dosage form of JAN101 to be used in clinical investigations is a sustained release (SR) tablet containing Sodium Nitrite drug substance.

Placebo

The comparison group will receive an inert placebo on the same schedule as the intervention group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Inert placebo formulation

Interventions

JAN101 SR

The dosage form of JAN101 to be used in clinical investigations is a sustained release (SR) tablet containing Sodium Nitrite drug substance.

Intervention Type: DRUG

Placebo

Inert placebo formulation

Intervention Type: OTHER

Other Intervention Names

Sodium Nitrite SR

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jennifer DeBerry

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer DeBerry, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Other Identifiers

UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300010657

Identifier Type: -

Identifier Source: org_study_id