OsteoarthritisNCT00794651
Osteoarthritis Bedside Testing Kit
An observational study of Osteoarthritis, run by Analgesic Solutions at 1 site in United States.
Trial summary
Develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: moderate to severe osteoarthritis of the knee .
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Analgesic Research, LLC
Needham, Massachusetts, 02494
Thomas A Eaton, PhD, 781-444-9605
About this study
Official title: 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
Read the 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.
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, testing kit, knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OA | moderate to severe osteoarthritis of the knee |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Analgesic Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nathaniel Katz, MD, Principal investigator, Analgesic ResearchThomas A Eaton, PhD, Study director, Analgesic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794651
- Sponsor's protocol ID
- AR_08_MK_01
- Status last verified
- Nov 2008
- First submitted
- 19 Nov 2008
- Last updated
- 20 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Bedside Pain Assessment Kit for Evaluating Effectiveness of Drugs for Osteoarthritis
- ClinicalTrials.gov ID
- NCT00794651
- Acronym / sponsor ID
- AR_08_MK_01
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, testing kit, knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Analgesic SolutionsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- May 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OA | – | –moderate to severe osteoarthritis of the knee |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- moderate to severe osteoarthritis of the knee .
Key inclusion criteria (8 listed)
- 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".
Key exclusion criteria (6 listed)
- • Subject is pregnant and/or breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Katz, MD principal investigator
Analgesic Research
Thomas A Eaton, PhD study director
Analgesic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Analgesic Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas A Eaton, PhD (781-444-9605, teaton@analgesicresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2008.