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Duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. Duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. We will use functional magnetic resonance imaging (FMRI) to investigate the neural and functional correlates of pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - sugar pill | Placebo Comparator |
| |
| Duloxetine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duloxetine | Drug | 30-60mg of duloxetine daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study. Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine. Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline. Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100. | 3 months |
| Neural Correlates of Pain Relief | Scores reflect the average connectivity strength of that region of interest to the rest of the cortex. There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3). Subscales are averaged. | 3 months |
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Inclusion Criteria:- Males aged 18-60
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| Name | Affiliation | Role |
|---|---|---|
| Sean Mackey | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| Label | URL |
|---|---|
| Description of the study and recruitment details | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Duloxetine | In the first 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. Following a -week washout period, in the second 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). |
| FG001 | Duloxetine Then Placebo | In the first 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). Following a -week washout period, in the second 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (8 Weeks) |
| |||||||||||||
| Washout (1 Week) |
| |||||||||||||
| Second Intervention (8 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Then Duloxetine | In the first 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. Following a -week washout period, in the second 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain | Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study. Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine. Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline. Values were converted to percent change in pain: [(baseline pain - end point pain)/baseline pain] x 100. | Posted | Mean | Standard Deviation | Percentage change from baseline to end | 3 months |
|
Adverse event data were collected throughout the duration of the study, for 12 weeks.
The clinicaltrials.gov definition of adverse event and/or serious adverse event was used to collect adverse event information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Includes all participants. Placebo: Placebo pill once daily Duloxetine: 30-60mg of duloxetine daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab | Stanford University | (650) 498-6477 | smackey@stanford.edu |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Drug |
Placebo pill once daily |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 |
| Duloxetine Then Placebo |
In the first 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). Following a -week washout period, in the second 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Neural Correlates of Pain Relief | Scores reflect the average connectivity strength of that region of interest to the rest of the cortex. There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3). Subscales are averaged. | Posted | Mean | Standard Deviation | Units on a scale | 3 months |
|
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
|