PainNCT02903238
Brain Morphometry in OA Patients Treated With Duloxetine
A study testing Duloxetine in people with Pain and Osteoarthritis, run by Northwestern University at 1 site in United States.
Trial summary
This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pain, Osteoarthritis
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40-85 years
- ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
- VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening)
- Knee OA for a minimum of 12 months
- Need for daily pain medication to manage symptoms of OA
Who cannot join
- Currently taking MAO inhibitors or any centrally acting drug for analgesia
- Narrow angle glaucoma
- Uncontrolled hypertension
- Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state
- If a female, pregnant, trying to become pregnant, or lactating
- Major depressive disorder
Show all 10Show fewer
- Substantial alcohol use or history of significant liver disease
- Diabetes, type 1 or type 2
- Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk
- Standard MRI safety exclusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine
This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.
Read the detailed description
In this study, all the participants will be receiving placebo. However this study will be single blinded in that participants will be told that they will be given a pill that may or may not help with their pain. The researcher, however, will know that all participants are receiving placebo
At the initial visit, participants will undergo screening to determine that they meet all inclusion and exclusion criteria. They will sign consent and then complete pain assessment instruments as well as one high resolution anatomical scan (T1) and one functional scan (a resting scar) in a 3 Tesla magnet. A single scanning session comprised of a 10 minute functional scan (a resting scan) will be done two weeks from the first scan and pain assessment instruments will be completed at this visit as well. After finishing this second scan (done two weeks after the initial scan), the participants will have completed the study.
- Conditions
- Pain, Osteoarthritis
- Being tested
- Duloxetine, Placebo Oral Tablet
- Keywords
- placebo, pain, osteoarthritis
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Duloxetine Delayed-Release Capsules: 30mg/day for 1 week ; 60mg/day for the remaining time
Placebo Oral TabletDrug
Also called Placebo
Lactose capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | placebo capsule Receives: Drug: Duloxetine; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Regional Gray Matter Density
Gray matter density (GMD) of the prefrontal cortex region identified as placebo biomarker. Placebo responders/non-responders were identified based on the VAS score. A minimum of 20% decrease in VAS score was needed to be qualified as responders.
GMD is a value between 0 and 1 representing the intensity of every brain voxels. The GMD of the prefrontal cortex region represent the average GMD of every voxels in this region.
Measured: 2 weeks
Secondary outcomes (2)
WOMAC Pain Index
Osteoarthritis (OA) specific pain and quality of life index (the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC). The WOMAC score is from 0 to 96 where 0 represent no pain and quality of life impairment due to OA and 96 represent the worst pain and quality of life impairment due to OA. The outcome is reported as the percent change from baseline to end of treatment (2 weeks).
Measured: 2 weeks
Overall Brain Neocortical Gray Matter Volume
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Apkar Apkarian, Northwestern University
- Investigators
- Apkar V Apkarian, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903238
- Sponsor's protocol ID
- STU00039556A
- Status last verified
- Jan 2017
- First submitted
- 26 Aug 2016
- Last updated
- 7 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data will be available at http://OpenfMRI.org
Publications
Tetreault P, Mansour A, Vachon-Presseau E, Schnitzer TJ, Apkarian AV, Baliki MN. Brain Connectivity Predicts Placebo Response across Chronic Pain Clinical Trials. PLoS Biol. 2016 Oct 27;14(10):e1002570. doi: 10.1371/journal.pbio.1002570. eCollection 2016 Oct.
PubMed 27788130
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Morphometric Study in Knee Osteoarthritis Patients Treated With Duloxetine
- ClinicalTrials.gov ID
- NCT02903238
- Acronym / sponsor ID
- STU00039556A
- Conditions
- Pain, Osteoarthritis
- Keywords
- placebo, pain, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 7 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.
Detailed description
In this study, all the participants will be receiving placebo. However this study will be single blinded in that participants will be told that they will be given a pill that may or may not help with their pain. The researcher, however, will know that all participants are receiving placebo
At the initial visit, participants will undergo screening to determine that they meet all inclusion and exclusion criteria. They will sign consent and then complete pain assessment instruments as well as one high resolution anatomical scan (T1) and one functional scan (a resting scar) in a 3 Tesla magnet. A single scanning session comprised of a 10 minute functional scan (a resting scan) will be done two weeks from the first scan and pain assessment instruments will be completed at this visit as well. After finishing this second scan (done two weeks after the initial scan), the participants will have completed the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Drug: Duloxetine, Drug: Placebo Oral Tabletplacebo capsule |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 40-85 years
- ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
- VAS pain score >5/10 within 48 hrs of the phone screen and visit 1 (Screening)
- Knee OA for a minimum of 12 months
- Need for daily pain medication to manage symptoms of OA
Key exclusion criteria (10 listed)
- Currently taking MAO inhibitors or any centrally acting drug for analgesia
- Narrow angle glaucoma
- Uncontrolled hypertension
- Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state
- If a female, pregnant, trying to become pregnant, or lactating
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 |
|---|---|---|
| DuloxetineAlso: CymbaltaDuloxetine Delayed-Release Capsules: 30mg/day for 1 week ; 60mg/day for the remaining time | Drug | Placebo |
| Placebo Oral TabletAlso: PlaceboLactose capsule | Drug | Placebo |
Primary outcome
Brain Regional Gray Matter Density
Time frame: 2 weeks
Gray matter density (GMD) of the prefrontal cortex region identified as placebo biomarker. Placebo responders/non-responders were identified based on the VAS score. A minimum of 20% decrease in VAS score was needed to be qualified as responders. GMD is a value between 0 and 1 representing the intensity of every brain voxels. The GMD of the prefrontal cortex region represent the average GMD of every voxels in this region.
2 secondary outcomes
WOMAC Pain Index
Time frame: 2 weeks
Overall Brain Neocortical Gray Matter Volume
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27788130Tetreault P, Mansour A, Vachon-Presseau E, Schnitzer TJ, Apkarian AV, Baliki MN. Brain Connectivity Predicts Placebo Response across Chronic Pain Clinical Trials. PLoS Biol. 2016 Oct 27;14(10):e1002570. doi: 10.1371/journal.pbio.1002570. eCollection 2016 Oct.
- Individual participant dataSharing planned: Yes. The data will be available at http://OpenfMRI.org
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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.
Apkar V Apkarian, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine in people with Pain and Osteoarthritis, run by Northwestern University 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 7 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Brain Regional Gray Matter Density (time frame: 2 weeks). 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 NCT02903238, 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 7 Mar 2017.