| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Chronic low back pain (CLBP) |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10024891 |
| E.1.2 | Term | Low back pain |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To assess the efficacy of duloxetine 60 mg once daily (QD) compared with placebo on the reduction of pain severity as measured by the Brief Pain Inventory (BPI) 24-hour average pain score ( in patients with chronic low back pain (CLBP) during a 12-week, double-blind treatment period. |
|
| E.2.2 | Secondary objectives of the trial |
• to evaluate duloxetine 60 mg QD versus placebo on patients’ perceived improvement as measured by PGI–Improvement
• to evaluate duloxetine 60 mg QD versus placebo on the improvement of functioning as measured by the RMDQ–24
• to assess the efficacy:
◦ BPI–Severity and Interference scores
◦ weekly mean of 24-hour average pain, average pain at night, and worst
daily pain scores
◦ response to treatment, as defined by a 30% or 50% reduction of the BPI
average pain score,
◦ sustained response to treatment
◦ cumulative distribution of BPI average pain score reduction
◦ CGI–Severity and
◦ POMS–Brief Form
• to assess the impact of treatment on patient-reported health outcomes:
◦ SF–36
◦ EQ–5D
◦ WPAI
• to evaluate the safety:
◦ discontinuation rates of patients
◦ TEAEs
◦ changes in laboratory test values
◦ changes in vital signs and weight
◦ Columbia Suicide Severity Rating Scale |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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 hepatic dysfunction, current jaundice, or positive Hepatitis B
surface antigen or positive Hepatitis C antibody
(HCV-Ab) regardless of alanine transaminase
[34] Patients with an ALT greater than or equal to 2 times the upper limit of
normal |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary efficacy measure is the Brief Pain Inventory (BPI) 24-hour average pain score. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 17 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 12 |
| E.8.9.1 | In the Member State concerned days | 14 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 12 |
| E.8.9.2 | In all countries concerned by the trial days | 14 |
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