Chronic pain: neuropathic pain and fibromyalgia MedDRA version: 8.1 Level: LLT Classification code 10033371 Term: Pain
Conditions
Interventions
Trade Name: Cymbalta
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
Danish Pain Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 18-75 years of age. 2. Patients with neuropathic pain. Diagnoses: peripheral nerve lesion, polyneuropathy in feet, spinal root compression, and post-herpetic neuralgia. 3. Patients with non-neuropathic pain. Diagnosis: fibromyalgia. 4. Daily pain present > 6 months. 5. Mean weekly pain score > 4 on an 11-point Likert scale the last week of the screening period. 6. Treatment with antidepressants (TCA, SSRI, SNRI, MAOI or others), gabapentin, pregabalin, and carbamazepine must be stopped at least two weeks before treatment phase. 7. Efficient contraception (women in the fertile age). 8. Written and verbal informed consent and letter of authority. 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
Exclusion criteria: Exclusion criteria: Before the beginning of the study 1. Hypersensitivity to the active substance or to any of the excipients in duloxetine. 2. Severe renal impairment (creatinine clearance 18 or Major Depression Inventory > 39.9. (Antidepressant medication will be initiated immediately). 3. Suicidal ideation and suicidal behaviours (treatment will be initiated immediately). 4. Pregnancy. 5. Lack of compliance with regard to intake of study medication and diary records. 6. Intake of pain and/or antidepressant medication not included in the study. 7. The patient cannot co-operate during the examination. 8. The patient wishes to leave the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: To analyse chronic pain patients with and without neuropathic pain with respect to: 1) Effect of a balanced serotonergic and noradrenergic reuptake inhibitor (duloxetine) on pain, anxiety and depression measures. 2) Relation between character and quality of pain, depression and anxiety. 3) Time course for changes in pain, anxiety and depression following treatment. ;Primary end point(s): The primary efficacy measure will be the reduction in the mean daily pain score as measured by VAS based on measures in the last week of treatment. Secondary efficacy measures include Psychological distress (Symptom Checklist-92), Hamilton Depression and Anxiety Rating Scale, Major Depression Inventory, Anxiety Inventory GAD-10, McGill Pain Questionnaire, Patient’s Global Impression of Improvement, assessment of sleep on an 11-point Likert Scale, thermal and pressure pain thresholds, pain areas, capsaicin test, response to cold pressor test and daily intake of concomitant medication during the trial. | — |
Countries
Denmark
Outcome results
None listed