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Effects and Safety of Epidural PDRN vs. Placebo

Primary Purpose

Spinal Stenosis Lumbar

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Polydeoxyribonucleotides

Normal saline

About this trial

This is an interventional treatment trial for Spinal Stenosis Lumbar

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Seoul national university Bundang hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Polydeoxyribonucleotide

Polydeoxyribonucleotide, Placebo

Placebo

Arm Description

Polydeoxyribonucleotide(PDRN) 5.625mg/3ml

Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)

Placebo (Normal saline)

Outcomes

Primary Outcome Measures

visual analogue scale(VAS)

This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)

Secondary Outcome Measures

visual analogue scale(VAS)

This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)

CGI(Clinicians Global Impression)

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.

treadmill test

walking distance

Full Information

NCT ID

NCT04401735

First Posted

May 11, 2020

Last Updated

May 22, 2020

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04401735

Brief Title

Effects and Safety of Epidural PDRN vs. Placebo

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

May 31, 2020 (Anticipated)

Study Completion Date

November 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Stenosis Lumbar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Polydeoxyribonucleotide

Arm Type

Experimental

Arm Description

Polydeoxyribonucleotide(PDRN) 5.625mg/3ml

Arm Title

Polydeoxyribonucleotide, Placebo

Arm Type

Experimental

Arm Description

Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (Normal saline)

Intervention Type

Drug

Intervention Name(s)

Polydeoxyribonucleotides

Intervention Description

PDRN injection to epidural space

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

Normal saline

Primary Outcome Measure Information:

Title

visual analogue scale(VAS)

Description

This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)

Time Frame

12 weeks post - injection

Secondary Outcome Measure Information:

Title

visual analogue scale(VAS)

Description

This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)

Time Frame

4, 8 weeks post - injection

Title

CGI(Clinicians Global Impression)

Description

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.

Time Frame

4, 8 weeks post - injection

Title

treadmill test

Description

walking distance

Time Frame

8 weeks post - injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lee pyongbok

Phone

82-2-787-7495

painfree@snubh.org

Facility Information:

Facility Name

Seoul national university Bundang hospital

City

Seongnam

State/Province

Kyoung-ki-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eunjoo Choi, MD

Phone

82-31-787-6572

ejchoi7956@gmail.com

First Name & Middle Initial & Last Name & Degree

Pyung Bok Lee, MD, PhD

12. IPD Sharing Statement

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Effects and Safety of Epidural PDRN vs. Placebo

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