Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01269866
Recruitment Status : Completed
First Posted : January 4, 2011
Last Update Posted : February 5, 2013
Information provided by (Responsible Party):
Dr. Jesus Gutierrez Stone, Brain Resource Center

Brief Summary:
The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain severity in patient with Systemic Lupus Erythematosus.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Drug: Cymbalta

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 : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot Study
Study Start Date : December 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arm Intervention/treatment
Cymbalta 60 to 120 mg
Drug: Cymbalta
Cymbalta 60 to 120 mg PO QD
Other Name: Duloxetine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. A diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification criteria, before visit 1.
  2. Able to swallow all required medication without opening or crushing.
  3. Male or female outpatient 18-65 years old at visit 1.
  4. Painful physical symptoms with a frequency > or equal to 2 times per week.
  5. Painful physical symptoms with a score > or equal to 4 on the BPI- SF average pain question at visits 1 and 2.
  6. Clinical Global Impression of Severity (CGI-S) score 3 or higher at visit 1.
  7. Able to speak, read and provide informed consent.
  8. Judged by the investigator to be reliable and agree to keep all appointments.

Exclusion Criteria:

  1. Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit.
  2. 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]
  3. 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.
  4. Serious medical illness, including any cardiovascular, hepatic, renal respiratory hematologic, endocrinologic or neurologic disease, or significant laboratory abnormality as judged by investigator.
  5. Substance/alcohol abuse or dependency in the last 6 months.
  6. History of serious suicide attempt or subject judged clinically to be at serious suicidal risk in the opinion of the investigator.
  7. Uncontrolled narrow angle glaucoma.
  8. Known hypersensitivity to Duloxetine or any active ingredients.
  9. 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)
  10. Have epilepsy or history of seizure disorder.
  11. Use of any of the prohibited medications including thioridazine (Mellaril), or all the potent CYP1A2 inhibitors, that use of these drugs are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01269866

United States, New York
Brain Resource Center
New york, New York, United States, 10023
Sponsors and Collaborators
Dr. Jesus Gutierrez Stone
Principal Investigator: Jesus Gutierrez Stone, MD Brain Resouce Center

Additional Information:
Responsible Party: Dr. Jesus Gutierrez Stone, MD, Brain Resource Center Identifier: NCT01269866     History of Changes
Other Study ID Numbers: F1J-US-X059
First Posted: January 4, 2011    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Dr. Jesus Gutierrez Stone, Brain Resource Center:
Lupus Pain
Systemic Lupus Erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents