Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Osteoarthritis Bedside Testing Kit

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Analgesic Solutions.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Analgesic Solutions
ClinicalTrials.gov Identifier:
NCT00794651
First received: November 19, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 19, 2008
November 19, 2008
January 2009
May 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Osteoarthritis Bedside Testing Kit
Development of a Bedside Pain Assessment Kit for Evaluating Effectiveness of Drugs for Osteoarthritis

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

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

moderate to severe osteoarthritis of the knee .

Osteoarthritis
Not Provided
OA
moderate to severe osteoarthritis of the knee
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
25
June 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact: Thomas A Eaton, PhD 781-444-9605 teaton@analgesicresearch.com
United States
 
NCT00794651
AR_08_MK_01
No
Nathaniel Katz, MD, Analgesic Research, LLC
Analgesic Solutions
Not Provided
Principal Investigator: Nathaniel Katz, MD Analgesic Research
Study Director: Thomas A Eaton, PhD Analgesic Research
Analgesic Solutions
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP