Osteoarthritis Bedside Testing Kit
Development of a Bedside Pain Assessment Kit for Evaluating Effectiveness of Drugs for Osteoarthritis
1 other identifier
observational
25
1 country
1
Brief Summary
Develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2009
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2008
CompletedFirst Posted
Study publicly available on registry
November 20, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedNovember 20, 2008
November 1, 2008
4 months
November 19, 2008
November 19, 2008
Conditions
Keywords
Study Arms (1)
OA
moderate to severe osteoarthritis of the knee
Eligibility Criteria
moderate to severe osteoarthritis of the knee .
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Analgesic Research, LLC
Needham, Massachusetts, 02494, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathaniel Katz, MD
Analgesic Research
- STUDY DIRECTOR
Thomas A Eaton, PhD
Analgesic Research
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 19, 2008
First Posted
November 20, 2008
Study Start
January 1, 2009
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
November 20, 2008
Record last verified: 2008-11