Effects and Safety of Epidural PDRN vs. Placebo

NCT ID: NCT04401735

Last Updated: 2020-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-11-01

Brief Summary

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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

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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

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Spinal Stenosis Lumbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Polydeoxyribonucleotide

Polydeoxyribonucleotide(PDRN) 5.625mg/3ml

Group Type EXPERIMENTAL

Polydeoxyribonucleotides

Intervention Type DRUG

PDRN injection to epidural space

Polydeoxyribonucleotide, Placebo

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

Group Type EXPERIMENTAL

Polydeoxyribonucleotides

Intervention Type DRUG

PDRN injection to epidural space

Normal saline

Intervention Type DRUG

Normal saline

Placebo

Placebo (Normal saline)

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline

Interventions

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Polydeoxyribonucleotides

PDRN injection to epidural space

Intervention Type DRUG

Normal saline

Normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pyung-Bok Lee

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul national university Bundang hospital

Seongnam, Kyoung-ki-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Lee pyongbok

Role: CONTACT

82-2-787-7495

Facility Contacts

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Eunjoo Choi, MD

Role: primary

82-31-787-6572

Other Identifiers

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SNUBHPAIN

Identifier Type: -

Identifier Source: org_study_id

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