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Osteoarthritis Bedside Testing Kit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00794651
Recruitment Status : Unknown
Verified November 2008 by Analgesic Solutions.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2008
Last Update Posted : November 20, 2008
Sponsor:
Information provided by:
Analgesic Solutions

Tracking Information
First Submitted Date November 19, 2008
First Posted Date November 20, 2008
Last Update Posted Date November 20, 2008
Study Start Date January 2009
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Osteoarthritis Bedside Testing Kit
Official Title Development of a Bedside Pain Assessment Kit for Evaluating Effectiveness of Drugs for Osteoarthritis
Brief Summary Develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis
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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population moderate to severe osteoarthritis of the knee .
Condition Osteoarthritis
Intervention Not Provided
Study Groups/Cohorts OA
moderate to severe osteoarthritis of the knee
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November¬†19,¬†2008)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2009
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00794651
Other Study ID Numbers AR_08_MK_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nathaniel Katz, MD, Analgesic Research, LLC
Study Sponsor Analgesic Solutions
Collaborators Not Provided
Investigators
Principal Investigator: Nathaniel Katz, MD Analgesic Research
Study Director: Thomas A Eaton, PhD Analgesic Research
PRS Account Analgesic Solutions
Verification Date November 2008