OsteoarthritisOASISNCT01377038
OASIS: Osteoarthritis Sensitivity Integration Study
A study testing Phenotype assessment in people with Osteoarthritis and Chronic Pain, run by University of Michigan at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Chronic Pain
- What is being tested?
- Phenotype assessment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with knee osteoarthritis as defined by American College of Rheumatology (ACR) criteria
- Males and females age greater than 50 years at time of screening
Who cannot join
- History of chronic kidney disease or moderate to severe hepatic impairment
- History of anemia
- Allergy or intolerance of drug intervention
- Inability to participate in outcome measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Central Pain Mechanisms in Osteoarthritis: A Longitudinal Cohort
The primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary objectives include the determination of which self-report and experimental pain measures best differentiate those who respond better to duloxetine than diclofenac.
Read the detailed description
This is a randomized, blinded, crossover, controlled study design comparing duloxetine and topical diclofenac for osteoarthritis pain.
The study cohort will be individuals who have a confirmed diagnosis of knee osteoarthritis. Subjects will be randomized only after all entry criteria have been met. These individuals will be evaluated at baseline, and then followed longitudinally following enrollment.
- Conditions
- Osteoarthritis, Chronic Pain
- Being tested
- Phenotype assessment
- Keywords
- Osteoarthritis, Chronic pain, Central pain
- Medical subject headings
- Osteoarthritis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenotype assessmentOther
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Active comparator | Phenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks. Receives: Other: Phenotype assessment |
| Diclofenac | Active comparator | Phenotype assessment prior to and after treatment with topical diclofenac four times daily Receives: Other: Phenotype assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Phillips, University of Michigan
- Investigators
- Kristine Phillips, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377038
- Sponsor's protocol ID
- 2011 HUM00044644
- Acronym
- OASIS
- Status last verified
- Oct 2016
- First submitted
- 16 Jun 2011
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Murphy SL, Lyden AK, Kratz AL, Fritz H, Williams DA, Clauw DJ, Gammaitoni AR, Phillips K. Characterizing Pain Flares From the Perspective of Individuals With Symptomatic Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2015 Aug;67(8):1103-11. doi: 10.1002/acr.22545.
PubMed 25580697
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Pain Mechanisms in Osteoarthritis: A Longitudinal Cohort
- ClinicalTrials.gov ID
- NCT01377038
- Acronym / sponsor ID
- OASIS / 2011 HUM00044644
- Conditions
- Osteoarthritis, Chronic Pain
- Keywords
- Osteoarthritis, Chronic pain, Central pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 20 Jun 2011 (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.
The primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary objectives include the determination of which self-report and experimental pain measures best differentiate those who respond better to duloxetine than diclofenac.
Detailed description
This is a randomized, blinded, crossover, controlled study design comparing duloxetine and topical diclofenac for osteoarthritis pain.
The study cohort will be individuals who have a confirmed diagnosis of knee osteoarthritis. Subjects will be randomized only after all entry criteria have been met. These individuals will be evaluated at baseline, and then followed longitudinally following enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Active comparator | Other: Phenotype assessmentPhenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks. |
| Diclofenac | Active comparator | Other: Phenotype assessmentPhenotype assessment prior to and after treatment with topical diclofenac four times daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with knee osteoarthritis as defined by American College of Rheumatology (ACR) criteria
- Males and females age greater than 50 years at time of screening
Key exclusion criteria (4 listed)
- History of chronic kidney disease or moderate to severe hepatic impairment
- History of anemia
- Allergy or intolerance of drug intervention
- Inability to participate in outcome measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenotype assessmentQuantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype | Other | Diclofenac, Duloxetine |
Primary outcome
Pain
Time frame: One month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 25580697Murphy SL, Lyden AK, Kratz AL, Fritz H, Williams DA, Clauw DJ, Gammaitoni AR, Phillips K. Characterizing Pain Flares From the Perspective of Individuals With Symptomatic Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2015 Aug;67(8):1103-11. doi: 10.1002/acr.22545.
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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.
Kristine Phillips, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenotype assessment in people with Osteoarthritis and Chronic Pain, run by University of Michigan 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 26 Oct 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01377038, which also lists 1 linked publication.
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 26 Oct 2016.