NCT05893160

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	JAN101 SR	The dosage form of JAN101 to be used in clinical investigations is a sustained release (SR) tablet containing Sodium Nitrite drug substance.
OTHER	Placebo	Inert placebo formulation

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-10-01
• Completion: 2028-08-01
• First posted: 2023-06-07
• Last updated: 2025-06-24

Regulatory

• FDA-regulated drug study