Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT01419405
Status:
COMPLETED
Last Update Posted:
2014-09-12
First Post:
2011-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pregabalin and Remifentanil - Analgesia and Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-11', 'studyFirstSubmitDate': '2011-06-30', 'studyFirstSubmitQcDate': '2011-08-17', 'lastUpdatePostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '123 sec x 4', 'description': 'Pain was caused by Cold Pressure Test'}], 'secondaryOutcomes': [{'measure': 'Ventilatory function', 'timeFrame': '10 min x 4', 'description': 'Respiratory frequence (breath/min), tidal volume (mL), minute volume (L)and expiratory end-tidal carbon dioxide tension (mmHg)'}, {'measure': 'Cognitive function', 'timeFrame': '4 min x 4', 'description': 'Cognitive function was tested using pc-tests like Cambridge Neuropsychological Test Automated Battery (CANTAB) and Stroop-test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['analgesia', 'acute experimental pain', 'cold pressor test', 'pregabalin', 'remifentanil'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'In this experimental study on healthy volunteers we explored the effect of pregabalin alone and in combination with remifentanil on acute experimental pain and ventilatory function.', 'detailedDescription': 'Pain during cold pressor test (CPT) was scored at all dose levels of remifentanil on a visual analogue scale (VAS 0-100 mm). Ventilatory function was measured by spirometry registering respiratory frequency (breaths/min), minute volume (L/min) and expiratory end-tidal carbon dioxide tension (mmHg).\n\nSide effects such as nausea and sedation were registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers,\n* \\> 18 yrs \\< 55 yrs,\n* negative pregnancy test\n\nExclusion Criteria:\n\n* Pregnancy,\n* nursing,\n* known heart-, lung- or liver disease,\n* kidney failure/peptic ulcers,\n* use of liver enzyme-inducing medications,\n* known allergy against the medications used in the trial,\n* use of psychotropic drugs, analgesics or alcohol used the last 24 hours before the trial,\n* body weight \\> 100 kg or 30% deviation from normal weight,\n* participant in other studies during the last 2 months,\n* individuals who do not master Norwegian language'}, 'identificationModule': {'nctId': 'NCT01419405', 'briefTitle': 'Pregabalin and Remifentanil - Analgesia and Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil', 'orgStudyIdInfo': {'id': '2011/1380-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregabalin/placebo', 'interventionNames': ['Drug: Pregabalin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'placebo/remifentanil', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo/placebo', 'interventionNames': ['Drug: sugar pill, saline infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Pregabalin/Remifentanil', 'interventionNames': ['Drug: Pregabalin', 'Drug: Remifentanil']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'hard capsule, 150 mg, 2 times, 2 days', 'armGroupLabels': ['Pregabalin/Remifentanil', 'Pregabalin/placebo']}, {'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': '50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL', 'armGroupLabels': ['Pregabalin/Remifentanil', 'placebo/remifentanil']}, {'name': 'sugar pill, saline infusion', 'type': 'DRUG', 'otherNames': ['Laktose monohydrat', 'NaCl 0,9%'], 'description': 'hard capsule, 150 mg, 2 times, 2 days, saline infusion', 'armGroupLabels': ['placebo/placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Universitetssykehus, Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Audun Stubhaug, MD, DMedSci, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital HF, Division of Critical Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}