Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT04401735
Status:
UNKNOWN
Last Update Posted:
2020-05-26
First Post:
2020-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects and Safety of Epidural PDRN vs. Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011089', 'term': 'Polydeoxyribonucleotides'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011119', 'term': 'Polynucleotides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-22', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale(VAS)', 'timeFrame': '12 weeks post - injection', 'description': 'This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)'}], 'secondaryOutcomes': [{'measure': 'visual analogue scale(VAS)', 'timeFrame': '4, 8 weeks post - injection', 'description': 'This is in pain measurement ranging from 0 when no pain to 10 when there is severe pain(low back pain)'}, {'measure': 'CGI(Clinicians Global Impression)', 'timeFrame': '4, 8 weeks post - injection', '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."}, {'measure': 'treadmill test', 'timeFrame': '8 weeks post - injection', 'description': 'walking distance'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Stenosis Lumbar']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Adults aged between 19-80 years old\n* 2\\. Radiological confirmation of spinal stenosis on MRI\n* 3\\. Neurogenic claudication greater thanVAS 4 of due to spinal stenosis\n* 4\\. Follow-up possible during 3 months the clinical trial\n\nExclusion Criteria:\n\n* Not able to comply fully with the protocol, including treatment, follow-up or study procedures\n* pregnant or feeding women\n* Alcohol/drug abuse\n* Anticoagulant medication'}, 'identificationModule': {'nctId': 'NCT04401735', 'briefTitle': 'Effects and Safety of Epidural PDRN vs. Placebo', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effects and Safety of PDRN (Polydeoxyribonucleotide) for Patient With Lumbar Spinal Stenosis Compared With Normal Saline in Randomized Placebo-Controlled Comparative Pilot Study', 'orgStudyIdInfo': {'id': 'SNUBHPAIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polydeoxyribonucleotide', 'description': 'Polydeoxyribonucleotide(PDRN) 5.625mg/3ml', 'interventionNames': ['Drug: Polydeoxyribonucleotides']}, {'type': 'EXPERIMENTAL', 'label': 'Polydeoxyribonucleotide, Placebo', 'description': 'Polydeoxyribonucleotide(PDRN) 5.625mg/3ml Placebo (Normal saline)', 'interventionNames': ['Drug: Polydeoxyribonucleotides', 'Drug: Normal saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (Normal saline)', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Polydeoxyribonucleotides', 'type': 'DRUG', 'description': 'PDRN injection to epidural space', 'armGroupLabels': ['Polydeoxyribonucleotide', 'Polydeoxyribonucleotide, Placebo']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Normal saline', 'armGroupLabels': ['Placebo', 'Polydeoxyribonucleotide, Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam', 'state': 'Kyoung-ki-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eunjoo Choi, MD', 'role': 'CONTACT', 'email': 'ejchoi7956@gmail.com', 'phone': '82-31-787-6572'}, {'name': 'Pyung Bok Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul national university Bundang hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'centralContacts': [{'name': 'Lee pyongbok', 'role': 'CONTACT', 'email': 'painfree@snubh.org', 'phone': '82-2-787-7495'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pyung-Bok Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}