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
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2019
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 11, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedMay 26, 2020
May 1, 2020
7 months
May 11, 2020
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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)
12 weeks post - injection
Secondary Outcomes (3)
visual analogue scale(VAS)
4, 8 weeks post - injection
CGI(Clinicians Global Impression)
4, 8 weeks post - injection
treadmill test
8 weeks post - injection
Study Arms (3)
Polydeoxyribonucleotide
EXPERIMENTALPolydeoxyribonucleotide(PDRN) 5.625mg/3ml
Polydeoxyribonucleotide, Placebo
EXPERIMENTALPolydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)
Placebo
PLACEBO COMPARATORPlacebo (Normal saline)
Interventions
PDRN injection to epidural space
Eligibility Criteria
You may qualify if:
- \. Adults aged between 19-80 years old
- \. Radiological confirmation of spinal stenosis on MRI
- \. Neurogenic claudication greater thanVAS 4 of due to spinal stenosis
- \. Follow-up possible during 3 months the clinical trial
You may not qualify if:
- Not able to comply fully with the protocol, including treatment, follow-up or study procedures
- pregnant or feeding women
- Alcohol/drug abuse
- Anticoagulant medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul national university Bundang hospital
Seongnam, Kyoung-ki-do, 463-707, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 11, 2020
First Posted
May 26, 2020
Study Start
November 1, 2019
Primary Completion
May 31, 2020
Study Completion
November 1, 2020
Last Updated
May 26, 2020
Record last verified: 2020-05