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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: October 17, 2013
Last updated: December 2, 2014
Last verified: December 2014
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.

Condition Intervention
Congenital Bleeding Disorder
Haemophilia A
Haemophilia A With Inhibitors
Haemophilia B
Haemophilia B With Inhibitors
Other: No treatment given

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Prevalence of acute (bleed-related) pain (percentage) [ Time Frame: At the first visit (only one study visit) ] [ Designated as safety issue: No ]
  • Prevalence of chronic (arthritic) pain (percentage) [ Time Frame: At the first visit (only one study visit) ] [ Designated as safety issue: No ]

Enrollment: 381
Study Start Date: October 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adult PWH Other: No treatment given
Subject will only fill out a questionnaire


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01988532

United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01988532     History of Changes
Other Study ID Numbers: HAEM-4073  U1111-1138-3464 
Study First Received: October 17, 2013
Last Updated: December 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases processed this record on December 08, 2016