Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 11:01 AM
Study NCT ID:
NCT00886106
Status:
UNKNOWN
Last Update Posted:
2009-11-18
First Post:
2009-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006930', 'term': 'Hyperalgesia'}], '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': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-17', 'studyFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2009-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area of pin prick hyperalgesia', 'timeFrame': '0-6 hours'}], 'secondaryOutcomes': [{'measure': 'Pain immediately after injection', 'timeFrame': '0-15 min'}, {'measure': 'Stimulus-response (SR) function to a set of modified rigid von Frey filaments (8-512 mN)', 'timeFrame': '0-6 hours'}, {'measure': 'Heat pain threshold within the area of mechanical hyperalgesia', 'timeFrame': '0-6 hours'}, {'measure': 'Mechanical pain threshold within the area of pin prick hyperalgesia, area of dynamic allodynia to brush', 'timeFrame': '0-6 hours'}, {'measure': 'Adverse effects', 'timeFrame': '30 and 59 min after infusion of study medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Capsaicin', 'Remifentanil', 'Hyperalgesia'], 'conditions': ['Hyperalgesia']}, 'descriptionModule': {'briefSummary': 'Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.\n\nOpioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.\n\nIntradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women, aged between 19 and 40 years\n* Body mass index between 15th and 85th percentile\n* Normal findings in the medical history and physical examination\n* Drug free for 1 week prior to the study day\n\nExclusion Criteria:\n\n* Regular use of medication especially analgesics\n* Abuse of alcoholic beverages, drug abuse\n* History of asthma\n* Participation in a clinical trial in the 2 weeks preceding the study\n* Symptoms of a clinically relevant illness in the 2 weeks before the first study day\n* Resting systolic blood pressure \\> 135 mmHg or diastolic blood pressure \\> 85 mmHg\n* Acute skin diseases like sunburn on the relevant areas or skin lesions\n* Pregnancy or breast feeding\n* Regular consumption of very spicy (capsaicin containing) food\n* Allergy against any medication used in the study protocol'}, 'identificationModule': {'nctId': 'NCT00886106', 'acronym': 'RemiAnes 1', 'briefTitle': 'The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Effect of High-dose Remifentanil on Established Capsaicin-induced Hyperalgesia in Human Volunteers', 'orgStudyIdInfo': {'id': 'RemiAnes 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Remifentanil', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Midazolam', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'description': 'Remifentanil (Ultiva®; Glaxo-Smith-Kline; Vienna, Austria) will be applied intravenously during 60 minutes through a dedicated infusion pump (TCI Alaris PK Syringe Pump, Cardinal Health, Baesweiler, Germany), with a Target Controlled Infusion (following the integrated software algorithm by Minto), reaching the initial 18ng/ml plasma concentration in 180 seconds. This corresponds to circa 0.7 µg kg-1 min-1', 'armGroupLabels': ['1']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Midazolam (Dormicum®; Roche; Vienna, Austria) will be applied intravenously as active placebo at a dose of 15 µg kg-1 min-1 over 5 minutes to mimic typical central nervous side effects of remifentanil', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Michael Andreae, MD', 'role': 'CONTACT', 'email': 'michael@andreae.org', 'phone': '+436769677181'}, {'name': 'Stephan Stellnberger, MD', 'role': 'CONTACT', 'email': 'stephan.stellnberger@meduniwien.ac.at', 'phone': '+436507333189'}, {'name': 'Astrid Chiari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Burkhard Gustorff, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael H Andreae, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephan Stellnberger, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hanna Opelt, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Juergen Sandkuehler, MD, PHD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ruth Drdla, PHD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Anaesthesia, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Michael Andreae, MD', 'role': 'CONTACT', 'email': 'michael@andreae.org', 'phone': '+436769677181'}, {'name': 'Stephan Stellnberger, MD', 'role': 'CONTACT', 'email': 'stephan.stellnberger@meduniwien.ac.at', 'phone': '+436507333189'}], 'overallOfficials': [{'name': 'Burkhard Gustorff, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Burkhard Gustorff', 'oldOrganization': 'Medical University of Vienna, Dept. Anaesthesia'}}}}