ClinicalTrials.Veeva

Menu

Effects and Safety of Epidural PDRN vs. Placebo

Seoul National University logo

Seoul National University

Status and phase

Unknown
Phase 4

Conditions

Spinal Stenosis Lumbar

Treatments

Drug: Normal saline
Drug: Polydeoxyribonucleotides

Study type

Interventional

Funder types

Other

Identifiers

NCT04401735
SNUBHPAIN

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

    1. Adults aged between 19-80 years old
    1. Radiological confirmation of spinal stenosis on MRI
    1. Neurogenic claudication greater thanVAS 4 of due to spinal stenosis
    1. Follow-up possible during 3 months the clinical trial

Exclusion criteria

  • Not able to comply fully with the protocol, including treatment, follow-up or study procedures
  • pregnant or feeding women
  • Alcohol/drug abuse
  • Anticoagulant medication

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

45 participants in 3 patient groups, including a placebo group

Polydeoxyribonucleotide
Experimental group
Description:
Polydeoxyribonucleotide(PDRN) 5.625mg/3ml
Treatment:
Drug: Polydeoxyribonucleotides
Polydeoxyribonucleotide, Placebo
Experimental group
Description:
Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)
Treatment:
Drug: Normal saline
Drug: Polydeoxyribonucleotides
Placebo
Placebo Comparator group
Description:
Placebo (Normal saline)
Treatment:
Drug: Normal saline

Trial contacts and locations

1

Loading...

Central trial contact

Lee pyongbok

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems