Effect of Duloxetine 60 mg Once Daily versus Placebo in Patients with Chronic Low Back Pain - HMGC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

[1] Male or female outpatients at least 18 years of age with chronic low back
pain as their primary painful condition and who have provided informed
consent by signing the appropriate informed consent document(s). Patients
must be competent and able to give their own informed consent.
[2] Based upon medical history, neurological examination and medical records,
have low back pain (T-6 or below) present on most days for the preceding
6 months or longer and fulfill all disease diagnostic criteria
[3] Have a score of >4 on the BPI average pain score at both Visits 1 and 2.
[4] Females of child-bearing potential must test negative on a pregnancy test at
Visit 1. Females of child-bearing potential must agree to utilize
medically acceptable and reliable means of birth control as determined by
the investigator during the study and for 1 month following the last dose of
the study. Women who are pregnant or breast-feeding may not participate in
the study.
[5] Have education level and degree of understanding such that they can
communicate intelligibly with the investigator and study coordinator.
[6] Are judged by the investigator to be reliable and agree to keep all
appointments for clinic visits, tests, and procedures required by the protocol
and have a valid home address.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[7] Are investigator site personnel directly affiliated with the study and/or are
immediate family of investigator site personnel directly affiliated with the
study.
[8] Are Lilly employees.
[9] Have received treatment within the last 30 days with a drug that has not
received regulatory approval for any indication at the time of study entry.
[10] Have a history of more than 1 low back surgery.
[11] Have a history of low back surgery within 12 months prior to study entry.
[12] Have received epidural steroids, facet block, nerve block or other invasive
procedures aimed to reduce low back pain within 1 month prior to Visit 1.
[13] Have previously completed or withdrawn from this study or any other study
investigating duloxetine. Note: patients who have been previously screened
for a duloxetine study other than this study and never received study drug will
be eligible for this study if they meet all current entry criteria.
[14] Completion of the daily electronic diaries for less than 70% of the days
between Visit 1 and Visit 2.
[15] Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective
disorder.
[16] Have major depressive disorder as determined using depression module of the
Mini-International Neuropsychiatric Interview
[17] Anticipated by the investigator to require use of nonsteroidal anti-inflammatory
drugs and includes acetaminophen and paracetamol, opioid
analgesics, or other protocol-excluded medication for the duration of the study
[18] Have ongoing or anticipated disability compensation or litigation issues, in the
best judgement of the investigator.
[19] Have a presence of any factors/conditions, medical or other, that in the
judgment of the investigator may interfere with performance of study outcome
measures, such as treatment-refractory history.
[20] Answer ‘yes’ to either question 4 or question 5 on the Suicidal Ideation portion of the C–SSRS or answer yes to any of the suicide-related behaviors on the
Suicidal Behavior portion of the C–SSRS; and the ideation or behavior
occurred within the past month.
[21] Have a positive urine drug screen for any substances of abuse or excluded
medication
[22] Have acute liver injury or severe cirrhosis
[23] Have a body mass index (BMI) over 40.
[24] Have uncorrected thyroid disease, uncontrolled narrow-angle glaucoma,
history of uncontrolled seizures, or uncontrolled or poorly controlled
hypertension.
[25] Have had previous exposure to duloxetine.
[26] Have serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory,
or hematologic illness, symptomatic peripheral vascular disease, or other
medical condition or psychiatric conditions that, in the opinion of investigator,
would compromise participation or be likely to lead to hospitalization during
the course of the study.
[27] Have known hypersensitivity to duloxetine, to its inactive ingredients, or to
multiple other medications.
[28] Are taking any excluded medications that cannot be discontinued at Visit 1.
[29] Treatment with a monoamine oxidase inhibitor within 14 days of Visit
2 or the potential need to use an MAOI during the study or within 5 days of
discontinuation of study drug.
[30] Are non-ambulatory or require the use of crutches or a walker.
[31] Have a history of substance abuse or dependence within the past year,
excluding nicotine and caffeine.
[32] Are pregnant or breast-feeding.

Exclusion Criteria for Regions with Prevalence of Chronic
Hepatitis B Virus
[33] History of hepati

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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