Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT04439994
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activation of miRNA and Proteins After Acute Experimental Pain. (miRNA: Micro RNA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012462', 'term': 'Saline Solution, Hypertonic'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D006982', 'term': 'Hypertonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups of subjects: one group will receive hypertonic injection (0.1 ml) and the other group will receive isotonic saline injection (0.1 ml)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'miRNA expression over time', 'timeFrame': 'Before injection', 'description': 'Plasma miRNA evaluation'}, {'measure': 'miRNA expression over time', 'timeFrame': '30 minutes post-injection', 'description': 'Plasma miRNA evaluation'}, {'measure': 'miRNA expression over time', 'timeFrame': '3 hours post-injection', 'description': 'Plasma miRNA evaluation'}, {'measure': 'miRNA expression over time', 'timeFrame': '24 hours post-injection', 'description': 'Plasma miRNA evaluation'}, {'measure': 'Protein expression over time', 'timeFrame': 'Before injection', 'description': 'Plasma protein evaluation'}, {'measure': 'Protein expression over time', 'timeFrame': '30 minutes post-injection', 'description': 'Plasma protein evaluation'}, {'measure': 'Protein expression over time', 'timeFrame': '3 hours post-injection', 'description': 'Plasma protein evaluation'}, {'measure': 'Protein expression over time', 'timeFrame': '24 hours post-injection', 'description': 'Plasma protein evaluation'}], 'secondaryOutcomes': [{'measure': 'Assessment of pain: visual analog scale', 'timeFrame': '20 minutes', 'description': 'Pain following capsaicin injection will be monitored for 20 minutes using a computerized 100 mm visual analog scale (eVAS software Aalborg University, Denmark), installed on a tablet.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertonic Saline', 'Isotonic Saline']}, 'referencesModule': {'references': [{'pmid': '36453122', 'type': 'DERIVED', 'citation': 'Giordano R, Gerra MC, Okutani H, Lo Vecchio S, Stensballe A, Petersen KK, Arendt-Nielsen L. The temporal expression of circulating microRNAs after acute experimental pain in humans. Eur J Pain. 2023 Mar;27(3):366-377. doi: 10.1002/ejp.2062. Epub 2022 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'In this experiment, the investigators would like to test the following:\n\n1. Does acute pain induced by hypertonic injection cause changes in plasma miRNA and protein expression ?\n2. Can these canges correlate with the development of local hyperalgesia?\n3. How does the plasma miRNA expression change over a duration of 24 hours post pain induction ?\n4. Which mRNA targets are potentially affected by acute pain?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women in the age 18-80 years\n* Speak and understand English\n\nExclusion Criteria:\n\n* Acute and chronic pain\n* Pregnancy or breastfeeding\n* Drug addiction defined as the use of cannabis, opioids or other drugs\n* Present or previous history of neurological, dermatological, immunological, musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. Neuropathy, muscular pain in the upper extremities, etc.)\n* Lack of ability to cooperate\n* Current use of medications that may affect the trial, such as antipsychotics and pain killers as well as systemic or topical steroids and anti-inflammatory drugs.\n* Skin diseases\n* Consumption of alcohol or painkillers 24 hours before the study days and between these\n* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)'}, 'identificationModule': {'nctId': 'NCT04439994', 'acronym': 'miRNA', 'briefTitle': 'Activation of miRNA and Proteins After Acute Experimental Pain. (miRNA: Micro RNA)', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'Activation of Plasma miRNA and Proteins as a Result of Acute Experimental Pain', 'orgStudyIdInfo': {'id': 'N-20200015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypertonic saline', 'description': 'Each participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.', 'interventionNames': ['Other: hypertonic saline', 'Procedure: Blood sampling']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic Saline', 'description': 'Each participant will be given i.d. in 0.1 mL volumes of a isotonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.', 'interventionNames': ['Other: Saline injection', 'Procedure: Blood sampling']}], 'interventions': [{'name': 'hypertonic saline', 'type': 'OTHER', 'description': 'The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution', 'armGroupLabels': ['Hypertonic saline']}, {'name': 'Saline injection', 'type': 'OTHER', 'description': 'The participant will be given i.d. in 0.1 mL volumes of a saline solution', 'armGroupLabels': ['Isotonic Saline']}, {'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected', 'armGroupLabels': ['Hypertonic saline', 'Isotonic Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Aalborg', 'state': 'North Denmark', 'country': 'Denmark', 'facility': 'Aalborg University', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '9220', 'city': 'Aalborg', 'state': 'North Denmark', 'country': 'Denmark', 'facility': 'AAlborg University', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Silvia Lo Vecchio', 'investigatorAffiliation': 'Aalborg University'}}}}