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

NCT01269866 | Completed

• 1 other identifier: F1J-US-X059
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

Lupus Pain; Lupus; Pain; Systemic Lupus Erythematosus; Duloxetine; Cymbalta

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (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

  Up to 8 weeks

Study Arms (1)

Cymbalta

OTHER

Cymbalta 60 to 120 mg

Drug: Cymbalta

Interventions

Cymbalta DRUG

Cymbalta 60 to 120 mg PO QD

Also known as: Duloxetine

Cymbalta

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Jesus Gutierrez Stone: lead

Study Sites (1)

Brain Resource Center

New York, New York, 10023, United States

Location

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jesus Gutierrez Stone, MD

  Brain Resouce Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: December 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

US (1)