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The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain severity in patient with Systemic Lupus Erythematosus.
Duloxetine (Cymbalta) is a reuptake inhibitor of both serotonin and norepinephrine. By increasing levels of serotonin and norepinephrine, the descending inhibitory pain pathways may function better. These pathways lessen the perception of pain. Results of double blind, placebo controlled, clinical trials investigating the effectiveness of Duloxetine (Cymbalta) have shown that at doses of 60 mg once a day or 60 mg twice a day, Duloxetine (Cymbalta) demonstrated significantly higher rates of treatment response for pain when compared to placebo.
Given the positive findings in other clinical trial studies for Duloxetine (Cymbalta) such as Diabetic Peripheral Neuropathy (Raskin et al., 2005) and Fibromyalgia (e.g. Arnold et al., 2005), the investigators hypothesize that Duloxetine (Cymbalta) may reduce the pain severity, frequency and intensity of exacerbations in patients with SLE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cymbalta | Other | Cymbalta 60 to 120 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cymbalta | Drug | Cymbalta 60 to 120 mg PO QD |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Brief Pan Inventory average pain questionnaire | This is a pilot study designed to explore the efficacy of Duloxetine (Cymbalta) 60 mg to 120 mg once daily (QD) on the reduction of pain in patients with Lupus pain. The primary objective will be measured by comparing changes from baseline and end of study in: 1. The Brief Pain Inventory (BPI-SF) average pain questionnaire. | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Change in Patient Global Impression of Improvement (PGI-I) score 2. Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score. 3. Change in Clinician Global of Impression (CGI) score |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesus Gutierrez Stone, MD | Brain Resouce Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Resource Center | New York | New York | 10023 | United States |
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| Label | URL |
|---|---|
| Click here for more information about this study | View source |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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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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| Up to 8 weeks |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |