Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT01988532
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2013-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 381}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2013-10-17', 'studyFirstSubmitQcDate': '2013-11-13', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of acute (bleed-related) pain (percentage)', 'timeFrame': 'At the first visit (only one study visit)'}, {'measure': 'Prevalence of chronic (arthritic) pain (percentage)', 'timeFrame': 'At the first visit (only one study visit)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A', 'Haemophilia A With Inhibitors', 'Haemophilia B', 'Haemophilia B With Inhibitors']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Wang M., Baumann K., Akins S., Funk S., Hernandez G., Kempton C., Buckner T., Cooper D. Pain, Functional Impairment, and Quality of Life (P-FIQ): Reliability of Patient-Reported Outcome (PRO) Instruments Assessing Pain and Function in US Adult People With Hemophilia (PWH). 14th WFH International Musculoskeletal Congress 2015; : Abstract number: P-224 Country: Northern Ireland City: Belfast'}, {'type': 'RESULT', 'citation': 'Baumann K., Akins S., Funk S., Hernandez G., Kempton C., Wang M., Buckner T., Cooper D. Functional Impairment, Pain, and Pain Management in Adult People with Haemophilia (PWH): Initial Lessons from the Pain Functional Impairment and Quality of Life (P-FIQ) Study. 14th WFH International Musculoskeletal Congress 2015; : Abstract number: MP-209 Country: Northen Ireland City: Belfast'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in the United States of America (USA). The aim of the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors with joint bleeding.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive adult PWH in the United States of America (USA) willing to consent to participation who have any history of joint bleeding or joint pain presenting for a comprehensive care visit during which joint range of motion will be assessed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult males able to provide consent and complete a survey in English\n* Congenital hemophilia A or B with or without inhibitors with any history of joint bleeding or joint pain\n* Presentation at the treatment center for a comprehensive annual visit where joint range of motion will be obtained\n* Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)\n\nExclusion Criteria:\n\n* Previous participation in this study'}, 'identificationModule': {'nctId': 'NCT01988532', 'briefTitle': 'Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia', 'orgStudyIdInfo': {'id': 'HAEM-4073'}, 'secondaryIdInfos': [{'id': 'U1111-1138-3464', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult PWH', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'Subject will only fill out a questionnaire', 'armGroupLabels': ['Adult PWH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08536', 'city': 'Plainsboro', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.33344, 'lon': -74.60043}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}