Pain, anxiety and depression in neuropathic and non-neuropathic pain: Effect of monoamine modulation.

Danish Pain Research Center0 sites86 target enrollmentJanuary 12, 2007

DrugsCymbalta

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Danish Pain Research Center
Enrollment: 86
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 12, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Danish Pain Research Center

Eligibility 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:

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\<30 ml/min.)
•3\. Liver disease resulting in hepatic impairment.
•4\. Comcomitant use of nonselective, irreversible or selective, reversible Monoamine Oxidase Inhibitors (MAOIs) within at least 14 days of discontinuing treatment with MAOI. Based on the half\-life of duloxetine, at least 5 days should be allowed after stopping duloxetine before starting an MAOI.
•5\. Comcomitant use of fluvoxamine, ciprofloxacin or enoxacine (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine.
•6\. Comcomitant use of serotonergic medicinal products: SSRI´s, TCA´s like clomipramine or amitriptyline, john´s wort (hypericum perforatum), SNRI like venlafaxine or triptans, tramadol, pethidine and tryptofan (risk of serotonine syndrome).
•7\. Comcomitant use of anticoagulants, medical products known to affect platelet function, diuretic medication, alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines), flecainide, propafenone and metoprolol (risk of interaction).
•8\. Serious or unstable medical illness (e.g. apoplexy, Alzheimer’s disease, affected platelet function, dehydration, epilepsy, hypertension, haemodialysis, hyponatremia, fructose intolerance, glucose\-galactose malabsorption, haemophilia, increased intraocular pressure, ischemic pain, uncontrolled narrow\-angle glaucoma, Raynaud´s phenomenon, sucrose\-isomaltase insufficiency, and previous case of anaphylactic shock reaction). Confirmed by medical history and, if possible, compared to medical records.
•9\. Current and previous diagnosis of mania, bipolar disorder, psychosis, severe agitation, imminent deliria, suicidal ideation, suicidal behaviour, alcohol or drug dependence (ICD\-10\). Confirmed by psychiatrical history and, if possible, compared to psychiatrical or medical records.