Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT01269866
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01269866
Study Brief:
Protocol Section:
NCT01269866