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Osteoarthritis Bedside Testing Kit
This study is not yet open for participant recruitment.
Verified by Analgesic Research, LLC, November 2008
Sponsored by: Analgesic Research, LLC
Information provided by: Analgesic Research, LLC
ClinicalTrials.gov Identifier: NCT00794651
  Purpose

Develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis


Condition
Osteoarthritis

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Development of a Bedside Pain Assessment Kit for Evaluating Effectiveness of Drugs for Osteoarthritis

Further study details as provided by Analgesic Research, LLC:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 25
Study Start Date: January 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
OA
moderate to severe osteoarthritis of the knee

Detailed Description:

Conduct a Focus group of subjects with painful osteoarthritis of the knee to evaluate potential kit for acceptability to subjects and investigators, and usability, clarity of instructions, appropriateness of the data capture, simplicity, subject and investigator burden, and overall impressions of the procedures.

Conduct a reliability and usability study with subjects with painful osteoarthritis of the knee to determine Intra-rater reliability, Inter-rater reliability, Kit reliability.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

moderate to severe osteoarthritis of the knee .

Criteria

Inclusion Criteria:

  • Subject is 50 years of age or older and has osteoarthritis of the knee.
  • Subject is able to communicate meaningfully in English and comply with all study procedures.
  • Subject is willing to voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the conduct of any study-specific procedures.
  • Subject has experienced a minimum duration of pain of at least 6 months.
  • For each of the last 15 days, pain level has remained at least a 3 on a Pain Intensity Numerical Rating (P-NRS) scale from 0 to 10; 0 means "no pain" and 10 means "worst pain imaginable".
  • Subject is ambulatory.
  • Subject has a primary diagnosis of osteoarthritis of the knee by medical history.
  • Subject must be willing to abstain from any pain medicine for 12 hours prior to the study.

Exclusion Criteria:

  • • Subject is pregnant and/or breast-feeding.

    • Subject has a medical condition, other than OA, that is not well-controlled with treatment; or the subject has any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain and other symptoms of OA.
    • Subject is not able to hold a stylus or pen.
    • Subject is not able to read a computer screen.
    • Subject has any chronic pain syndrome (e.g., fibromyalgia) that, in the investigator's opinion, would interfere with the assessment of pain and/or other symptoms of OA.
    • In the judgment of the investigator, the subject has a psychiatric or psychological disorder that would interfere with the completion of the study, confound the study results or pose patient risk.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794651

Contacts
Contact: Thomas A Eaton, PhD 781-444-9605 teaton@analgesicresearch.com

Locations
United States, Massachusetts
Analgesic Research, LLC
Needham, Massachusetts, United States, 02494
Sponsors and Collaborators
Analgesic Research, LLC
Investigators
Principal Investigator: Nathaniel Katz, MD Analgesic Research
Study Director: Thomas A Eaton, PhD Analgesic Research
  More Information

Responsible Party: Analgesic Research, LLC ( Nathaniel Katz, MD )
Study ID Numbers: AR_08_MK_01
Study First Received: November 19, 2008
Last Updated: November 19, 2008
ClinicalTrials.gov Identifier: NCT00794651  
Health Authority: United States: Institutional Review Board

Keywords provided by Analgesic Research, LLC:
osteoarthritis
testing kit
knee

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Pain
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009