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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01269866 |
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Date of registration:
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03/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus
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Scientific title:
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Duloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot Study |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01269866 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Jesus Gutierrez Stone, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brain Resouce Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Cymbalta
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Primary Outcome(s)
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Changes in the Brief Pan Inventory average pain questionnaire
[Time Frame: Up to 8 weeks]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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F1J-US-X059
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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