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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Jesus Gutierrez Stone, Brain Resource Center
ClinicalTrials.gov Identifier:
NCT01269866
First received: January 3, 2011
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Systemic Lupus Erythematosus
Drug: Cymbalta

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Brain Resource Center:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]
    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


Enrollment: 26
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cymbalta
Cymbalta 60 to 120 mg
Drug: Cymbalta
Cymbalta 60 to 120 mg PO QD
Other Name: Duloxetine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269866

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

Additional Information:
No publications provided

Responsible Party: Dr. Jesus Gutierrez Stone, MD, Brain Resource Center
ClinicalTrials.gov Identifier: NCT01269866     History of Changes
Other Study ID Numbers: F1J-US-X059
Study First Received: January 3, 2011
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brain Resource Center:
Lupus Pain
Lupus
Pain
Systemic Lupus Erythematosus
Duloxetine
Cymbalta

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014