Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Duloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot Study|
- Changes in the Brief Pan Inventory average pain questionnaire [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
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.
- 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 [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
- Change in Patient Global Impression of Improvement (PGI-I) score
- Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
- Change in Clinician Global of Impression (CGI) score
|Study Start Date:||December 2010|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Cymbalta 60 to 120 mg
Cymbalta 60 to 120 mg PO QD
Other Name: Duloxetine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01269866
|United States, New York|
|Brain Resource Center|
|New york, New York, United States, 10023|
|Principal Investigator:||Jesus Gutierrez Stone, MD||Brain Resouce Center|