Effects and Safety of Epidural PDRN vs. Placebo

May 22, 2020 updated by: Pyung-Bok Lee, Seoul National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyoung-ki-do
      • Seongnam, Kyoung-ki-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Adults aged between 19-80 years old
  • 2. Radiological confirmation of spinal stenosis on MRI
  • 3. Neurogenic claudication greater thanVAS 4 of due to spinal stenosis
  • 4. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Polydeoxyribonucleotide
Polydeoxyribonucleotide(PDRN) 5.625mg/3ml
Drug: Polydeoxyribonucleotides
PDRN injection to epidural space
EXPERIMENTAL: Polydeoxyribonucleotide, Placebo
Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)
Drug: Normal saline
Normal saline
Drug: Polydeoxyribonucleotides
PDRN injection to epidural space
PLACEBO_COMPARATOR: Placebo
Placebo (Normal saline)
Drug: Normal saline
Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale(VAS)
Time Frame: 12 weeks post - injection
This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)
12 weeks post - injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale(VAS)
Time Frame: 4, 8 weeks post - injection
This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)
4, 8 weeks post - injection
CGI(Clinicians Global Impression)
Time Frame: 4, 8 weeks post - injection
7 point scale that requires the clinician to assess how much the patient's illness has improved(grade 0) or worsened(grade 7) relative to a baseline state at the beginning of the intervention.
4, 8 weeks post - injection
treadmill test
Time Frame: 8 weeks post - injection
walking distance
8 weeks post - injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ANTICIPATED)

May 31, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (ACTUAL)

May 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBHPAIN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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