Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-01 @ 10:08 AM
Study NCT ID:
NCT01296334
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2011-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D006930', 'term': 'Hyperalgesia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2011-02-14', 'studyFirstSubmitQcDate': '2011-02-14', 'lastUpdatePostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic and antihyperalgesic effects', 'timeFrame': '0 to 180 min after a first degree burn injury', 'description': 'Analgesic effect is assessed by change in primary hyperalgesia (pain rating \\[VAS\\]) Antihyperalgesic effect is assessed by reduction in area of hyperalgesia (sq. cm) VAS-area under curve is calculated for 0, 60, 120 and 180 min after first degree burn injury'}], 'secondaryOutcomes': [{'measure': 'Difference in analgesic/antihyperalgesic profile between pain-sensitive and pain-non-sensitive individuals', 'timeFrame': '0-180 min after first degree burn injury', 'description': 'The ratios between areas under curve (0-180 min after first degree burn injury) for analgesic effect assessed by change in primary hyperalgesia (pain rating VAS\\])and antihyperalgesic effect assessed by reduction in area of hyperalgesia (sq. cm).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['opioids', 'analgesia', 'secondary hyperalgesia', 'quantitative sensory testing', 'inflammatory injury'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '16154698', 'type': 'BACKGROUND', 'citation': 'Koppert W, Ihmsen H, Korber N, Wehrfritz A, Sittl R, Schmelz M, Schuttler J. Different profiles of buprenorphine-induced analgesia and antihyperalgesia in a human pain model. Pain. 2005 Nov;118(1-2):15-22. doi: 10.1016/j.pain.2005.06.030. Epub 2005 Sep 9.'}, {'pmid': '23359655', 'type': 'RESULT', 'citation': 'Ravn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU. Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res. 2013;6:23-38. doi: 10.2147/JPR.S36827. Epub 2013 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'Tissue injury is associated with pain from the injured site (primary hyperalgesia) and pain from non-injured tissue in the vicinity of the trauma (secondary hyperalgesia). In the present study we investigate primary and secondary hyperalgesia in healthy volunteers following an experimental first degree burn injury.\n\nThe objectives are:\n\n* to compare analgesic and anti-hyperalgesic effects of two opioids (morphine and buprenorphine).\n* to investigate if these effects are related to the volunteers individual pain sensitivity', 'detailedDescription': 'Please refer to:\n\nRavn P, Secher EL, Skram U, Therkildsen T, Christrup LL, Werner MU (2013) Morphine- and buprenorphine-induced analgesia and antihyperalgesia in a human inflammatory pain model: a double-blind, randomized, placebo-controlled, five-arm crossover study. J Pain Res 6: 23-38. 10.2147/JPR.S36827 \\[doi\\];jpr-6-023 \\[pii\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individuals\n* adequate psychomotor performance to perform pain tests\n* pain-sensitive or pain-nonsensitive according to prespecified criteria\n\nExclusion Criteria:\n\n* known allergy to morphine or buprenorphine\n* prior adverse experiences with opioids\n* history of abuse\n* females not taking P-pills\n* skin lesions on the test-sites\n* suffering from chronic pain\n* medication with analgesics\n* BMI \\> 28\n* smoker'}, 'identificationModule': {'nctId': 'NCT01296334', 'acronym': 'PASORII', 'briefTitle': 'Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Analgesic and Antihyperalgesic Effects of Morphine and Buprenorphine Following an Experimental Inflammatory Injury in Volunteers.', 'orgStudyIdInfo': {'id': 'H-2-2010-115'}, 'secondaryIdInfos': [{'id': '2010-022903-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'morphine low dose', 'description': 'morphine infusion 10 mg over a 210 min period', 'interventionNames': ['Drug: morphine LO']}, {'type': 'EXPERIMENTAL', 'label': 'morphine high dose', 'description': 'morphine infusion 20 mg over a 210 min period', 'interventionNames': ['Drug: Morphine Hi']}, {'type': 'EXPERIMENTAL', 'label': 'buprenorphine low dose', 'description': 'buprenorphine infusion 0.3 mg over a 210 min period', 'interventionNames': ['Drug: Buprenorphine LO']}, {'type': 'EXPERIMENTAL', 'label': 'buprenorphine high dose', 'description': 'buprenorphine infusion 0.6 mg over a 210 min period', 'interventionNames': ['Drug: Buprenorphine Hi']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo (normal saline) infusion 0.6 mg over a 210 min period', 'interventionNames': ['Other: saline']}], 'interventions': [{'name': 'morphine LO', 'type': 'DRUG', 'otherNames': ['Morfin SAD'], 'description': 'intravenous infusion, 10 mg, once, 4 hours', 'armGroupLabels': ['morphine low dose']}, {'name': 'Morphine Hi', 'type': 'DRUG', 'otherNames': ['Morfin SAD'], 'description': 'intravenous infusion, 20 mg, once, 4 hours', 'armGroupLabels': ['morphine high dose']}, {'name': 'Buprenorphine LO', 'type': 'DRUG', 'otherNames': ['Temgesic'], 'description': 'intravenous infusion, 0.3 mg, once, 4 hours', 'armGroupLabels': ['buprenorphine low dose']}, {'name': 'Buprenorphine Hi', 'type': 'DRUG', 'otherNames': ['Temgesic'], 'description': 'intravenous infusion, 0.6 mg, once, 4 hours', 'armGroupLabels': ['buprenorphine high dose']}, {'name': 'saline', 'type': 'OTHER', 'otherNames': ['0.9% NaCl'], 'description': 'intravenous infusion, 0.9% saline, once, 4 hours', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Zelo Phase One Clinical Trial Unit, Bispebjerg Hospital'}], 'overallOfficials': [{'name': 'Mads U Werner, MD, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Multidisciplinary Pain Centre 7612, Rigshospitalet, Blegdamsvej 9, DK 2100 Copenhagen O'}, {'name': 'Lona L Christrup, MSc, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pharmaceutical Faculty, Copenhagen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mads u werner', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norpharma A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'mads u werner', 'investigatorAffiliation': 'University of Copenhagen'}}}}