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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. |
Register:
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EUCTR |
Last refreshed on:
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11 September 2012 |
Main ID: |
EUCTR2008-002248-40-NL |
Date of registration:
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02/06/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Effect of Duloxetine 60 mg Once Daily versus Placebo in Patients with Chronic Low Back Pain - HMGC
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Scientific title:
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Effect of Duloxetine 60 mg Once Daily versus Placebo in Patients with Chronic Low Back Pain - HMGC |
Date of first enrolment:
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04/08/2008 |
Target sample size:
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400 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002248-40 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Germany
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Netherlands
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Spain
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Chronic low back pain (CLBP) MedDRA version: 9.1
Level: LLT
Classification code 10024891
Term: Low back pain
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Intervention(s)
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Trade Name: Cymbalta Product Name: Duloxetine Product Code: LY248686 Pharmaceutical Form: Gastro-resistant capsule, hard INN or Proposed INN: Duloxetine CAS Number: 116539594 Current Sponsor code: LY248686 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Gastro-resistant capsule, hard Route of administration of the placebo: Oral use
Trade Name: Cymbalta Product Name: Duloxetine Product Code: LY248686 Pharmaceutical Form: Gastro-resistant capsule, hard INN or Proposed INN: Duloxetine CAS Number: 116539594 Current Sponsor code: LY248686 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Gastro-resistant capsule, hard Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: 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.
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Secondary Objective: • 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
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Primary end point(s): The primary efficacy measure is the Brief Pain Inventory (BPI) 24-hour average pain score.
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Secondary ID(s)
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F1J-MC-HMGC
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Source(s) of Monetary Support
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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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