Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT00599768
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2008-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2008-01-11', 'studyFirstSubmitQcDate': '2008-01-23', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the optimal cut-off score of ID Pain-T Questionnaire for screening of neuropathic pain', 'timeFrame': 'end of study'}], 'secondaryOutcomes': [{'measure': 'Evaluate the predictive power of ID Pain-T Questionnaire for diagnosis of neuropathic pain', 'timeFrame': 'end of study'}, {'measure': 'Develop and evaluate validity of a short form diagnostic tool based on DN4 structure', 'timeFrame': 'end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neuralgia', 'Nerve Pain', 'Neuropathic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081175&StudyName=Development%20and%20Validation%20for%20Taiwan%20Version%20ID%20Pain%20Questionnaire%20%28ID%20Pain-T%29%20and%20DN4%20Questionnaire.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This prospective cohort and multi-site study aims to develop Taiwan version (ID Pain-T) based on the original versions of ID Pain and also DN4, and validate both ID Pain-T and DN4 applied in Taiwanese subjects at the clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients of non-headache pain for more than 30 days and those whose age is more than 18 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects without headache pain over 30 days and at least 18 years old who will visit the clinic, inclusive of male and female.\n* Subjects who are able to complete the ID Pain-T Questionnaire.\n\nExclusion Criteria:\n\n* Subjects who are illiterate or unable to complete questionnaire.\n* Subjects who are currently participating in another study or have participated in another pain study within one month of study entry.\n* Subjects with low back pain are unable to participate in this study; as the sciatica caused by the piriformis (exclusive of the other types of sciatic pain), lumbago, unclear identification in nerve injury (e.g. complex regional pain syndrome type I) or mixed origin (e.g. cancer pain).'}, 'identificationModule': {'nctId': 'NCT00599768', 'briefTitle': 'Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Development and Validation for Taiwan Version ID Pain Questionnaire (ID Pain-T) and DN4 Questionnaire.', 'orgStudyIdInfo': {'id': 'A0081175'}, 'secondaryIdInfos': [{'id': 'TWN-2006-CNS-001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ID-Pain DN4 Questionnaire', 'type': 'OTHER', 'description': 'This is a non-interventional questionnaire validation study'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}