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NCT01988532 Clinical Trial

Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia

Congenital Bleeding Disorder Clinical Trial

Official title:
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01988532
Other study ID # HAEM-4073
Secondary ID U1111-1138-3464
Status Completed
Phase N/A
First received October 17, 2013
Last updated January 17, 2017
Start date October 2013
Est. completion date October 2014

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 381
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Adult males able to provide consent and complete a survey in English

- Congenital hemophilia A or B with or without inhibitors with any history of joint bleeding or joint pain

- Presentation at the treatment center for a comprehensive annual visit where joint range of motion will be obtained

- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)

Exclusion Criteria:

- Previous participation in this study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No treatment given
Subject will only fill out a questionnaire

Locations
Country Name City State
United States Novo Nordisk Investigational Site Plainsboro New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of acute (bleed-related) pain (percentage) At the first visit (only one study visit)
Primary Prevalence of chronic (arthritic) pain (percentage) At the first visit (only one study visit)
See also
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Completed NCT01205724 - Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A Phase 1
Completed NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State Phase 1
Completed NCT00108797 - Trial of NovoSeven® in Haemophilia - Joint Bleeds Phase 4
Completed NCT01493778 - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A Phase 3
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Completed NCT00951405 - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors Phase 2
Completed NCT01876745 - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan N/A
Completed NCT02920398 - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A Phase 1
Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A
Completed NCT01238367 - A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 Phase 1

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