Viewing Study NCT01127906


Ignite Creation Date: 2025-12-26 @ 4:03 PM
Ignite Modification Date: 2026-02-26 @ 12:21 AM
Study NCT ID: NCT01127906
Status: COMPLETED
Last Update Posted: 2010-09-23
First Post: 2010-05-20
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'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': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-22', 'studyFirstSubmitDate': '2010-05-20', 'studyFirstSubmitQcDate': '2010-05-20', 'lastUpdatePostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of PF-04531083 by using the Heat Pain Tolerance Threshold in the area of UVB-induced erythema (HPTTu) endpoint at 2, 4, 6 and 24 hours.', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Heat Pain Perception Threshold in the area of UVB-induced erythema (HPPTu) at 2, 4, 6 and 24 hours.', 'timeFrame': '24 hours'}, {'measure': 'Heat Pain Perception Threshold on control skin (HPPTc) at 2, 4, 6 and 24 hours', 'timeFrame': '24 hours'}, {'measure': 'Summary of plasma concentrations of PF-04531083', 'timeFrame': '24 hours'}, {'measure': 'Exploratory colorimetric data collected from baseline and MED test exposure areas', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers', 'cross-over', 'randomized', 'placebo and active controlled', 'heat pain', 'UVB-Induced pain model'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1351003&StudyName=Study%20To%20Assess%20The%20Effect%20Of%20PF-04531083%20On%20Heat%20Pain%20In%20Healthy%20Volunteers%20With%20Ultraviolet%20Light%20Sensitized%20Skin', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers.\n* Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.\n\nExclusion Criteria:\n\n* Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy).\n* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.\n* Subjects with inadequate cardiac function (ECG demonstrating prolonged QTc interval at screening).\n* Subjects with inadequate or excessive sensitivity to UVB light.'}, 'identificationModule': {'nctId': 'NCT01127906', 'briefTitle': 'Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double-Blind, Double-Dummy, Placebo And Active Comparator Controlled 4-Period Cross-Over Study To Assess The Effect Of PF-04531083 On Heat Pain In The UVB-Induced Pain Model In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B1351003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Randomized cross-over sequence', 'description': 'Randomized unbalanced sequence of incomplete block design with replicates within sequence', 'interventionNames': ['Drug: PF-04531083 100mg', 'Drug: PF-04531083 2000mg', 'Drug: Placebo suspension', 'Drug: Placebo tablet', 'Drug: Oxycodone 20mg']}], 'interventions': [{'name': 'PF-04531083 100mg', 'type': 'DRUG', 'description': 'Oral PF-04531083 100mg suspension single dose', 'armGroupLabels': ['Randomized cross-over sequence']}, {'name': 'PF-04531083 2000mg', 'type': 'DRUG', 'description': 'Oral PF-04531083 2000mg suspension single dose', 'armGroupLabels': ['Randomized cross-over sequence']}, {'name': 'Placebo suspension', 'type': 'DRUG', 'description': 'Oral Placebo suspension (matched to PF-04531083 suspension)', 'armGroupLabels': ['Randomized cross-over sequence']}, {'name': 'Placebo tablet', 'type': 'DRUG', 'description': 'Oral Placebo tablet (matched to Oxycodone)', 'armGroupLabels': ['Randomized cross-over sequence']}, {'name': 'Oxycodone 20mg', 'type': 'DRUG', 'description': 'Oral Oxycodone 20mg (Oxycontin) controlled release formulation', 'armGroupLabels': ['Randomized cross-over sequence']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}