NCT04401735

Effects and Safety of Epidural PDRN vs. Placebo

Effects and Safety of PDRN (Polydeoxyribonucleotide) for Patient With Lumbar Spinal Stenosis Compared With Normal Saline in Randomized Placebo-Controlled Comparative Pilot Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, double-blind clinical study to assess the clinical application and outcomes with epidural PDRN versus Normal saline injection in patients with spinal stenosis.

Detailed description

Patients who are already planning to receive an Transforaminal epidural block from their clinician will be approached by study members on the day of their injection. If enrolled, the patients will be contacted every 2 weeks for 4 weeks to determine the severity of pain and degree of pain relief from the injection.

Conditions

• Spinal Stenosis Lumbar

Interventions

Type	Name	Description
DRUG	Polydeoxyribonucleotides	PDRN injection to epidural space
DRUG	Normal saline	Normal saline

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-05-31
• Completion: 2020-11-01
• First posted: 2020-05-26
• Last updated: 2020-05-26

Locations

1 site across 1 country: South Korea