- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01166048
Comparison of the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
Objective:
The objective of this study is to compare the efficacy of duloxetine in the treatment of patients with chronic low back pain with a radicular component to placebo.
Study hypothesis:
Duloxetine is a new substance now in use for the treatment of neuropathic pain. It has proven its efficacy in diabetic peripheral neuropathy and fibromyalgia in several trials. The investigators therefore hypothesize that duloxetine will be efficacious in patients with chronic low back pain and a radicular component.
Study Rationale:
Chronic low back pain is an extremely common diagnosis. However, therapeutic options for the condition are limited and therapy remains difficult. Duloxetine has proven its efficacy in patients with neuropathic pain and may also be useful in chronic low back pain. If the investigators are able to show a benefit for patients in the duloxetine arm, the substance may constitute a further treatment alternative in chronic low back pain.
Study Design:
Prospective, randomized, double-blind placebo-controlled cross over study. Patients will be administered duloxetine for 4 weeks followed by a 2 week wash-out phase after which they will be medicated with placebo for 4 weeks. A second group of patients will receive the medication in reversed order. The primary study endpoint is constituted the weekly mean of VAS-Score in the last week of each treatment period. Secondary endpoints are defined as use of rescue medication, Beck Depression Inventory score, Health related Quality of Life SF-36 score and side effects/adverse events.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Low back pain ( below L1)
- Chronic pain, >6 months
- Visual Analogue Scale (VAS) ≥ 5
- Back pain with radicular component defined as pain with a burning, tingling sensation within the anatomic distribution of the nerve root and diagnosed by painDETECT questionnaire
- Failed back surgery
Exclusion Criteria:
- Current mood disorder (dysthymia, bipolar mood disorder)
- Major Depression > 12 months (Beck Depression Inventory Score ≥ 18)
- History of a psychoactive substance use disorder within the preceding 12 months
- Major coexisting medical illness (e.g. severe heart failure, pulmonary hypertension, renal insufficiency)
- Glaucoma
- Acute myocardial infarction
- uncontrolled hypertension
- Prostate hyperplasia
- History of convulsion
- Pregnancy; women of childbearing age will be required to use contraceptives during the duration of the study. Furthermore a pregnancy test will be performed prior to the beginning of the study and once a month during the study period.
- Participation in a clinical trial in the 3 weeks preceding the study
- Allergy to study medication
Use of the following medication:
- opioids except for tramadol,
- benzodiazepines other than indicated at low doses for sleep disorders
- antineuropathic medication including except for that specified in the study protocol
- muscle relaxants
- antidepressants other than indicated at low doses for sleep disorders
- NSAID, Paracetamol
- non-selective MAO-Inhibitors
- Fluvoxamine, Ciprofloxacin, Enoxacin
- Selective Serotonin-reuptake Inhibitors (SSRI)
if tapering of these drugs is impossible before inclusion.
- Impaired kidney function (Creatinine > 1.5mg/dl)
- Impaired hepatic function (GOT, GPT >2 fold standard levels)
- Patients who are not able to understand the study measures and are not able to complete pain assessment forms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Milk powder pill
Patients will receive 2 placebo pills per day for a period of 4 weeks.
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Patients will receive 120mg of Duloxetine for the duration of 2 weeks after a dosage titration of 2 weeks according to the following scheme: (p=placebo) day: 1 2 3 4 5 6 7: p-30mg p-30mg p-30mg p-30 mg p-30mg p-30mg p-60mg day: 8 9 10 11 12 13 14: p-60 mg p-60 mg p-60mg p-60mg p-60mg p-60mg 60-60mg
2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.
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EXPERIMENTAL: Duloxetine
In the experimental arm of the study patients will receive duloxetine, which will be titrated up to a dosage of 120mg over a period of two weeks and continued at this dosage for two weeks.
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Patients will receive 120mg of Duloxetine for the duration of 2 weeks after a dosage titration of 2 weeks according to the following scheme: (p=placebo) day: 1 2 3 4 5 6 7: p-30mg p-30mg p-30mg p-30 mg p-30mg p-30mg p-60mg day: 8 9 10 11 12 13 14: p-60 mg p-60 mg p-60mg p-60mg p-60mg p-60mg 60-60mg
2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10)
Time Frame: Week 4 of study period
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Operationally a VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end (left= no pain, right=worst imaginable pain).The patient marks the current subjective pain intensity on the scale.
This is converted to a numeric value by measurement from the left side of the scale.
(Units 1-10)
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Week 4 of study period
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Weekly mean pain intensity in study phase II (Visual analogue score, units 1-10)
Time Frame: Week 10 of study period
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Week 10 of study period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of rescue medication in study phase I
Time Frame: Use of rescue medication in week 4 of study period
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Patients will be allowed Metamizol (500mg up to 3g per day) and Tramadol drops (20 ggt. up to 6 times per day) as rescue medication.
Rescue medication will be recorded daily in a patient diary.
Use of rescue medication will be scored as follows: 0=no rescue medication; 1=metamizol; 2=tramadol
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Use of rescue medication in week 4 of study period
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Beck Depression Inventory score in phase I of study period
Time Frame: Beck Depression Inventory score at week 4 of study period
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Subjects will be asked to perform the Beck Depression Inventory at screening and at week 4.
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Beck Depression Inventory score at week 4 of study period
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Health related Quality of Life SF-36 score in phase I of study period
Time Frame: Health related Quality of Life SF-36 score at week 4 of study period.
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Subjects will be asked to fill out the Health related Quality of Life SF-36 questionnaire at screening and at the end of each treatment period (placebo and verum)
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Health related Quality of Life SF-36 score at week 4 of study period.
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painDetect score in phase I of study period
Time Frame: painDetect score at week 4 of study period.
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Subjects will be asked to complete the painDetect questionnaire at screening and the end of each treatment period (placebo and verum).
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painDetect score at week 4 of study period.
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Use of rescue medication in phase II of study period
Time Frame: Use of rescue medication in week 10 of study period.
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Use of rescue medication in week 10 of study period.
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Beck Depression Inventory score in phase II of study period
Time Frame: Beck Depression Inventory score at week 10 of study period.
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Beck Depression Inventory score at week 10 of study period.
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Health related Quality of Life SF-36 score in phase II of study period.
Time Frame: Health related Quality of Life SF-36 score at week 10 of study period.
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Health related Quality of Life SF-36 score at week 10 of study period.
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painDetect score in phase II of study period
Time Frame: painDetect score at week 10 of study period.
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painDetect score at week 10 of study period.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthias Oehmke, MD, Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna,
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- SPDP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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