Trial record 2 of 312 for:    "hemophilia"

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01988532
First received: October 17, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 ]

Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 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

  Eligibility

Ages Eligible for Study:   18 Years and older
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.

Criteria

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 ClinicalTrials.gov identifier: NCT01988532

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

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01988532     History of Changes
Other Study ID Numbers: HAEM-4073, U1111-1138-3464
Study First Received: October 17, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014