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

Sponsors

Lead Sponsor: Seoul National University Hospital

Source Seoul National University Hospital
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.

Overall Status Recruiting
Start Date November 1, 2019
Completion Date November 1, 2020
Primary Completion Date May 31, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
visual analogue scale(VAS) 12 weeks post - injection
Secondary Outcome
Measure Time Frame
visual analogue scale(VAS) 4, 8 weeks post - injection
CGI(Clinicians Global Impression) 4, 8 weeks post - injection
treadmill test 8 weeks post - injection
Enrollment 45
Condition
Intervention

Intervention Type: Drug

Intervention Name: Polydeoxyribonucleotides

Description: PDRN injection to epidural space

Intervention Type: Drug

Intervention Name: Normal saline

Description: Normal saline

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

Gender: All

Minimum Age: 19 Years

Maximum Age: 80 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Lee pyongbok

Phone: 82-2-787-7495

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Seoul national university Bundang hospital Eunjoo Choi, MD 82-31-787-6572 [email protected] Pyung Bok Lee, MD, PhD Principal Investigator
Location Countries

Korea, Republic of

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul National University Hospital

Investigator Full Name: Pyung-Bok Lee

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Polydeoxyribonucleotide

Type: Experimental

Description: Polydeoxyribonucleotide(PDRN) 5.625mg/3ml

Label: Polydeoxyribonucleotide, Placebo

Type: Experimental

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

Label: Placebo

Type: Placebo Comparator

Description: Placebo (Normal saline)

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov