Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:33 PM
Study NCT ID:
NCT01935206
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2013-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of High Dose Naloxone on Secondary Hyperalgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006930', 'term': 'Hyperalgesia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009270', 'term': 'Naloxone'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-24', 'studyFirstSubmitDate': '2013-08-19', 'studyFirstSubmitQcDate': '2013-08-30', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Mechanical Pain Thresholds at primary hyperalgesia site before and after naloxone/placebo infusion', 'timeFrame': '0h, 168h, 168h30min', 'description': 'Mechanical Pain Thresholds will be assessed with pinprick stimulators at baseline and after infusion of naloxone/placebo at the primary hyperalgesia site (following a first degree burn) and in the contralateral leg.'}], 'primaryOutcomes': [{'measure': 'Change in Secondary hyperalgesia area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo', 'timeFrame': '1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn', 'description': 'Areas of secondary hyperalgesia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.'}], 'secondaryOutcomes': [{'measure': 'Change in allodynic area (cm2) surrounding a first-degree burn injury before and after infusion of naloxone/placebo', 'timeFrame': '1h, 2h, 3h, 168h, 168h15min, 168h30min post-burn', 'description': 'Areas of allodynia surrounding a first degree burn-injury will be assessed before and after infusion of naloxone/placebo.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['secondary hyperalgesia', 'allodynia', 'mechanical pain threshold', 'naloxone', 'endogenous opioids', 'pain'], 'conditions': ['Hyperalgesia', 'Pain', 'Naloxone', 'Opioid Antagonist']}, 'descriptionModule': {'briefSummary': 'Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.\n\nAnimal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.\n\nIn the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim therefore to show that latent sensitization is present in humans and is modulated by endogenous opioids.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy man\n* written informed consent\n* ASA 1-2\n* BMI 18 \\< BMI \\< 30\n* normal ultrasound examination of the heart\n* normal ECG\n* urin sample without traces of opioids\n\nExclusion Criteria:\n\n* volunteers, who do not understand the Danish language\n* participation in another experimental trial in the previous 60 days\n* nerve damage or skin lesions in the assessment areas\n* neurological or psychiatric condition\n* use of psycho-active drugs\n* abuse of alcohol or drugs\n* chronic pain\n* regular use of pain-killers (\\> 1 a week)\n* allergy against morphine or other opioids (including naloxone)\n* use of prescription drugs 1 week prior to the trial\n* use of over-the-counter medication 48 hours prior to the trial\n* urin sample with traces of opioids\n* volunteer is not suitable for the trial according to the investigator's consideration"}, 'identificationModule': {'nctId': 'NCT01935206', 'briefTitle': 'Effect of High Dose Naloxone on Secondary Hyperalgesia', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Effect of a High-dose Naloxone Infusion on Secondary Hyperalgesia After a First-degree Burn', 'orgStudyIdInfo': {'id': 'H-2-2012-174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Naloxone (2 mg/kg)', 'description': 'The effect of naloxone (2 mg/kg) on secondary hyperalgesia 168 hours after a first-degree burn-injury is compared to the placebo effect.', 'interventionNames': ['Drug: Naloxone (2 mg/kg)']}], 'interventions': [{'name': 'Naloxone (2 mg/kg)', 'type': 'DRUG', 'armGroupLabels': ['Naloxone (2 mg/kg)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Dept Anaesthesiology HOC, 4231, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Multidisciplinary Pain Center', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Joergen B Dahl, M.D., DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept Anaesthesiology, HOC, 4231, Rigshospitalet'}, {'name': 'Mads U. Werner, M.D., Ph.D., DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multidisciplinary Pain Center, 7612, Rigshospitalet, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Manuel Pereira', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}