Spinal Stenosis LumbarPhase 4NCT04401735
Effects and Safety of Epidural PDRN vs. Placebo
A Phase 4 study testing Polydeoxyribonucleotides and Normal saline in people with Spinal Stenosis Lumbar, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- Polydeoxyribonucleotides and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2019to 1 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not able to comply fully with the protocol, including treatment, follow-up or study procedures
- pregnant or feeding women
- Alcohol/drug abuse
- Anticoagulant medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul national university Bundang hospital
Seongnam, Kyoung-ki-do, 463-707
Eunjoo Choi, MD, 82-31-787-6572, ejchoi7956@gmail.com
Pyung Bok Lee, MD, PhD
About this study
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
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.
Read the 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.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- Polydeoxyribonucleotides, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolydeoxyribonucleotidesDrug
PDRN injection to epidural space
Normal salineDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Polydeoxyribonucleotide | Experimental | Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Receives: Drug: Polydeoxyribonucleotides |
| Polydeoxyribonucleotide, Placebo | Experimental | Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline) Receives: Drug: Polydeoxyribonucleotides; Drug: Normal saline |
| Placebo | Placebo comparator | Placebo (Normal saline) Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks post - injection
Secondary outcomes (3)
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)
Measured: 4, 8 weeks post - injection
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.
Measured: 4, 8 weeks post - injection
treadmill test
walking distance
Measured: 8 weeks post - injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Nov 2019
- Primary completion31 May 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pyung-Bok Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401735
- Sponsor's protocol ID
- SNUBHPAIN
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04401735
- Acronym / sponsor ID
- SNUBHPAIN
- Conditions
- Spinal Stenosis Lumbar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Polydeoxyribonucleotide | Experimental | Drug: PolydeoxyribonucleotidesPolydeoxyribonucleotide(PDRN) 5.625mg/3ml |
| Polydeoxyribonucleotide, Placebo | Experimental | Drug: Polydeoxyribonucleotides, Drug: Normal salinePolydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline) |
| Placebo | Placebo comparator | Drug: Normal salinePlacebo (Normal saline) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Not able to comply fully with the protocol, including treatment, follow-up or study procedures
- pregnant or feeding women
- Alcohol/drug abuse
- Anticoagulant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolydeoxyribonucleotidesPDRN injection to epidural space | Drug | Polydeoxyribonucleotide, Polydeoxyribonucleotide, Placebo |
| Normal salineNormal saline | Drug | Placebo, Polydeoxyribonucleotide, Placebo |
Primary outcome
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)
3 secondary outcomes
visual analogue scale(VAS)
Time frame: 4, 8 weeks post - injection
CGI(Clinicians Global Impression)
Time frame: 4, 8 weeks post - injection
treadmill test
Time frame: 8 weeks post - injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polydeoxyribonucleotides and Normal saline in people with Spinal Stenosis Lumbar, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee pyongbok (82-2-787-7495, painfree@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale(VAS) (time frame: 12 weeks post - injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.