Neuropathic pain syndrome associated with diabetic peripheral neuropathy, post herpetic neuralgia, post traumatic or post operative peripheral neuropathy, and leprosy.
Conditions
Interventions
Investigational group (Cristália ketamine-clonidine combination): 76 patients suffering of neuropathic pain will receive dextro ketamine 1%in combination with clonidine 0.03% topical gel cream. The pr
Drug
D26.660
Sponsors
Faculdade de Medicina do ABC
Cristalia Produtos Químicos Farmacêuticos Ltda
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Signed and dated informed consent form. Male or female patients of any ethnic origin aged 18 years or over. Outpatient status. Patients with diagnosis of neuropathic pain associated with diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), post traumatic or post operative peripheral neuropathy and leprosy; DPN defined as peripheral, somatic or autonomic nerve damage attributable solely to diabetes mellitus; PHN defined as pain lasting longer than three months beyond the crusting of the skin lesions after an acute attack of Herpes zoster.Patients with moderate to severe pain all or most of the time, that has persisted for three months or longer (for patients with post herpetic neuralgia pain present for more than three months after healing of Herpes zoster skin rash. Patients with DN4 score 4. Patients with pharmacological therapies for neuropathic pain [anticonvulsants, selective and non- selective serotonin reuptake inhibitors, antidepressants, gabapentoids, nonsteroidal anti-inflammatory drugs (NSAIDS), salicylates, or acetaminophen] should be dose stabilized for at least 14 days before randomization and be willing to maintain therapy constant, avoid changes, or initiate new therapies throughout the study. Patients with normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-report questionnaires. Women of childbearing potential must have a negative urine pregnancy test before randomization and must be using and willing to continue using adequate contraception (hormonal, double barrier or intrauterine device, according to medical indication) or be sexually abstinent during the study, and must not be lactating. Post-menopausal women for less than two years are considered of childbearing potential.
Exclusion criteria
Exclusion criteria: Patients with severe pain associated with conditions other than diabetic peripheral neuropathy, post herpetic neuralgia, leprosy and post traumatic or post operative peripheral neuropathy [e.g., significant vasculitis, collagen vascular disorder, familial neuropathy, alcoholism, pernicious anemia, hepatitis, malignancy, syphilis, chronic inflammatory demyelinating polyradiculopathy, human immunodeficiency virus (HIV), medication-induced neuropathy, vitamin B12 deficiency, and others]. Patients with other sustained pain with intensity at, or greater than neuropathic pain. Patients with major depression requiring treatment. Patients with known allergy to clonidine or ketamine. Patients with ongoing use of a monoamine oxidase inhibitor. Patients with current use of antiarrhythmic drugs of class one (sodium channel blockers). Patients with uncontrolled diabetes mellitus (fasting blood glucose ? 130 mg/dL) or uncontrolled hypertension (systolic blood pression ? 180mmHg or diastolic ? 110mmHg). Patients using implanted medical device (e.g., spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for pain treatment. Patients clinically hypotensive with a resting diastolic blood pressure 2 times the upper limit of normal or values for alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times the upper limit of normal at screening. Patients treated with ketamine or clonidine oral, transdermal patch, or topical gel over the last four weeks prior to the screening visit. Patients that used any topically applied pain medication within a period of 7 days before the screening. Patients with evidence of clinically significant peripheral vascular disease as evidenced by history of intermittent claudication or evidence of vascular ulcers, including venous stasis ulcers. Patients receiving any medications that could affect neuropathic pain not at stable dose for at least 14 days prior to the screening visit (other than medications containing NSAIDs and aspirin which must be stable for seven days prior to the screening visit). Patients receiving complementary therapies (acupuncture, TENS, central blockage)and/or "alternative medicines" (naturopathy, homeopathy, etc.) for pain treatment of 7 days prior to the screening visit. Patients with history of malignancy within the previous five years. Patients that have been hospitalized within 30 days of the screening visit, or planning to have a surgery during the study period. Patients with any dermatologic condition that could affect study drug absorption. Patients carrying pacemaker, impantable cardiac defibrillator, or cardiac resynchronizer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of at least 2.3 points in pain intensity measured by a scale of 11 points, where 0 means no pain and 10 the most intense pain possible, by comparing the measurements of baseline and after 12 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of pain intensity from baseline periods and after 1, 4 and 8 weeks of treatment, using a numerical scale for Pain Intensity Rating of 11 points;Points of comparison of Catastrophizing scale of pain between the baseline period and after 1, 4, 8 and 12 weeks of treatment;Comparison of the need for rescue medication use between the arms;Comparison between the arms of the global evaluation of treatment by the patient (GPI) after 12 weeks of treatment;Comparison between the arms of the global evaluation of treatment by the patient (CGI) after 12 weeks of treatment;Change in quality of life at week 0, 1, 4, 8, and 12, as measured by Quality of Life Short Form survey (SF-12). ;Incidence of adverse events (AE). | — |
Countries
Brazil
Contacts
Public ContactRosana Athiê
Cristalia Produtos Químicos Farmacêuticos Ltda
Outcome results
None listed