Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT00773760
Status:
UNKNOWN
Last Update Posted:
2009-08-06
First Post:
2008-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MOR and COMT SNP Polymorphism and Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'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'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-04', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative assessments include PCA use (e.g., number of patient demands, total morphine administered) in each 24-h interval during the 48-h study period - primary endpoint.', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'No secondary outcome endpoint', 'timeFrame': 'no time frame'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['opioids', 'COMT', 'SNP', 'analgesia', 'postoperative pain'], 'conditions': ['Pain Relief']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.itk.ee', 'label': 'East Tallinn Central Hospital'}]}, 'descriptionModule': {'briefSummary': 'Patients with certain polymorphism in the MOR and COMT genes will display differences in their response to analgesics.', 'detailedDescription': "After tissue injury, there is great interindividual variability among patients in the amount of pain experienced (pain intensity and duration of pain) and in the degree of pain relief from analgesics. In experimental settings, Single Nucleotide Polymorphisms (SNP) at the MOR and COMT genes have been found to alter the response to opioids in in vitro models and in human.We will collect clinical data on one hundred patients undergoing surgery. We will obtain DNA extracted via PCR techniques from the patients' blood and we will identify SNPs at the mu opioid receptor and catechol-O-methyltransferase genes. We will analyze the data to search for correlation between clinical patterns of postoperative pain and opioid effects and SNPs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and older\n* Give informed consent to participate in this study\n\nExclusion Criteria:\n\n* Neurologic or psychiatric disease sufficient, in the clinical judgment of the investigator, to compromise informed consent or data collection\n* ASA classification score 3 or above\n* Patients with past or present history of substance abuse.\n* Patients with a history of chronic pain requiring daily analgesic use for more then one month.\n* Patients with a current diagnosis of anxiety or depression requiring medical treatment\n* Patients allergic to morphine'}, 'identificationModule': {'nctId': 'NCT00773760', 'briefTitle': 'MOR and COMT SNP Polymorphism and Pain', 'organization': {'class': 'OTHER', 'fullName': 'East Tallinn Central Hospital'}, 'officialTitle': 'Does mu Opioid Receptor (MOR) and Catechol-O-methyltransferase (COMT) Genes Polymorphism Correlate of Clinical Postoperative Pain and Response to Analgesics', 'orgStudyIdInfo': {'id': 'ITK-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'dosing', 'interventionNames': ['Other: SNP genotyping']}], 'interventions': [{'name': 'SNP genotyping', 'type': 'OTHER', 'description': 'Coded blood specimens will be transported to the Department of Gene Technology TTÜ and genotyping analysis will be performed. Lymphocytes will be isolated from blood specimens using Ficol-Paq gradients, and genomic DNA isolated using a salting-out procedure. Variants of the MOR gene and other genes of interests will be performed by DNA sequence analysis of PCR-amplified DNA, using primers located in flanking intron sequence. All methods proposed are currently in operation in the respective facilities.', 'armGroupLabels': ['dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11312', 'city': 'Tallinn', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Peeter Ross, MD', 'role': 'CONTACT', 'email': 'peeter.ross@itk.ee', 'phone': '372 6973002'}, {'name': 'Yuri Kolesnikov', 'role': 'CONTACT', 'email': 'yuri.kolesnikov@itk.ee', 'phone': '372 6973002'}, {'name': 'Boris Gabovits, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yuri Kolesnikov, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yuri Kolesnikov MD PhD', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}], 'overallOfficials': [{'name': 'Yuri Kolesnikov, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ETCH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Tallinn Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'A.Veske PhD Director of Department of Gene Technology', 'oldOrganization': 'TTU'}}}}