- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01269866
Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus
Duloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot Study
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New york, New York, United States, 10023
- Brain Resource Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification criteria, before visit 1.
- Able to swallow all required medication without opening or crushing.
- Male or female outpatient 18-65 years old at visit 1.
- Painful physical symptoms with a frequency > or equal to 2 times per week.
- Painful physical symptoms with a score > or equal to 4 on the BPI- SF average pain question at visits 1 and 2.
- Clinical Global Impression of Severity (CGI-S) score 3 or higher at visit 1.
- Able to speak, read and provide informed consent.
- Judged by the investigator to be reliable and agree to keep all appointments.
Exclusion Criteria:
- Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit.
- Pregnancy, nursing. Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) who are not using a medically accepted means of contraception (For example, oral contraceptive, contraceptive patch, implant, Depo-Provera®, Norplant®, reliable barrier method/devices [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]
- Positive urine drug screen for any substance of abuse. Note: If the subject has a positive drug screen for a substance at Visit 1, a retest may be performed prior to Visit 2 if, in the judgment of the investigator, there is an acceptable explanation for the positive result. A retest is not required for a positive result for benzodiazepines or hypnotics if the investigator confirms use is within protocol criteria.
- Serious medical illness, including any cardiovascular, hepatic, renal respiratory hematologic, endocrinologic or neurologic disease, or significant laboratory abnormality as judged by investigator.
- Substance/alcohol abuse or dependency in the last 6 months.
- History of serious suicide attempt or subject judged clinically to be at serious suicidal risk in the opinion of the investigator.
- Uncontrolled narrow angle glaucoma.
- Known hypersensitivity to Duloxetine or any active ingredients.
- Treatment with a MAOI within 14 days prior to Visit 2 or have the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug. (See Concomitant Medication List)
- Have epilepsy or history of seizure disorder.
- Use of any of the prohibited medications including thioridazine (Mellaril), or all the potent CYP1A2 inhibitors, that use of these drugs are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cymbalta
Cymbalta 60 to 120 mg
|
Cymbalta 60 to 120 mg PO QD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the Brief Pan Inventory average pain questionnaire
Time Frame: Up to 8 weeks
|
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
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: Up to 8 weeks
|
|
Up to 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jesus Gutierrez Stone, MD, Brain Resouce Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Connective Tissue Diseases
- Lupus Erythematosus, Systemic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- F1J-US-X059
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Systemic Lupus Erythematosus
-
SanofiCompletedCutaneous Lupus Erythematosus-Systemic Lupus ErythematosusJapan
-
Kyowa Kirin Co., Ltd.RecruitingHealthy Volunteers | Systemic Lupus Erythematosus (SLE) | Cutaneous Lupus Erythematosus (CLE)Japan
-
Second Xiangya Hospital of Central South UniversityNational Natural Science Foundation of China; Hunan Provincial Natural Science... and other collaboratorsActive, not recruitingCutaneous Lupus Erythematosus | Systemic Lupus Erythematosus RashChina
-
University Hospital, BrestRecruitingSystemic Lupus Erythematosus (SLE)France
-
Beijing InnoCare Pharma Tech Co., Ltd.RecruitingSystemic Lupus Erythematosus, SLEChina
-
TJ Biopharma Co., Ltd.TerminatedSystemic Lupus Erythematosus (SLE)China
-
AstraZenecaActive, not recruitingActive Systemic Lupus ErythematosusThailand, Korea, Republic of, Philippines, China, Taiwan, Hong Kong
-
Novartis PharmaceuticalsActive, not recruitingSystemic Lupus Erythematosus (SLE)Hungary, Spain, Germany, Israel, Thailand, France, Russian Federation, China, Japan, Taiwan, Korea, Republic of, Poland, Australia, Argentina, Czechia
-
AstraZenecaPRA Health SciencesCompletedActive Systemic Lupus ErythematosusUnited States, France, Germany, Spain, Belgium, Russian Federation, Japan, Korea, Republic of, Argentina, Bulgaria, South Africa, Mexico, Canada, Brazil, Lithuania
-
Novartis PharmaceuticalsNot yet recruitingSystemic Lupus Erythematosus, SLE
Clinical Trials on Cymbalta
-
Dr. Reddy's Laboratories LimitedCompleted
-
New York State Psychiatric InstituteEli Lilly and CompanyCompletedDysthymic Disorder | Depressive Disorder NOSUnited States
-
Dr. Reddy's Laboratories LimitedCompleted
-
National Cancer Institute, EgyptRecruitingPost-mastectomy Pain SyndromeEgypt
-
Beijing Chao Yang HospitalCapital Medical UniversityRecruiting
-
University of Michigan Rogel Cancer CenterAmerican Cancer Society, Inc.Completed
-
Yale UniversityWithdrawnPostpartum Depression | Major Depressive DisorderUnited States
-
Yale UniversityVA Connecticut Healthcare SystemCompletedPosttraumatic Stress DisorderUnited States
-
University of Michigan Rogel Cancer CenterEli Lilly and CompanyCompleted