Neuropathic pain Nervous System Diseases Polyneuropathy in diseases
Conditions
Interventions
Centrally-acting oral opioid anlagesic (017) titrated to effect over a 4-week phase with matched placebo arm.
Sponsors
Purdue Pharma Canada
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For diabetic neuropathy patients: 1. Stable glycaemic control 2. Patients with pain in the lower extremities on a daily basis and one or more signs or symptoms of peripheral neuropathy not attributable to any other cause 3. Patients with absent or decreased ankle reflexes and loss of perception of 128 Hz vibration of the great toe For post-herpetic neuralgia patients: 1. Primary diagnosis of PHN defined by pain for at least three months after healing of a herpes zoster skin rash For all patients: 1. Male or non-pregnant females at least 18 years of age 2. Patients who answer yes to at least four items on the the neuropathic pain diagnostic questionnaire (DN4) 3. Patients whose pain has been of moderate intensity on most days for at least three months 4. Patients who have required the use of analgesic medication for at least three months
Exclusion criteria
Exclusion criteria: 1. Patients who do not have stable glycaemic control (HbA1c greater than 2 x normal) or whose anti-diabetic therapy is likely to require adjustment during the study 2. Patients with peripheral neuropathy attributable to other causes 3. Significant pain of other origin that may obscure the assessment of efficacy 4. Patients whose opioid requirement may exceed eight tablets of acetaminophen plus codeine (300/30 mg) or analgesic equivalent per day 5. Patients with true allergy to acetaminophen or any opioid, sufficient that therapy is contraindicated 6. Patients with any of the following medical conditions: 6.1. Active, severe psychiatric disorder, including severe depression 6.2. Postural hypotension 6.3. Clinically significant hepatic dysfunction (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [Alk Phos] greater than 2 x normal) 6.4. Symptomatic coronary artery peripheral vascular disease 6.5. Intermittent claudication 6.6. Brittle diabetes 6.7. Low serum cobalamin (vitamin B12) 6.8. Abnormal serum folic acid levels 6.9. Colostomy, ileostomy or shortened gastrointestinal (GI) transit time 6.10. Active or recent peptic ulcer or gastrointestinal (GI) inflammatory disease 6.11. Epilepsy, history of seizures or recognised risk for seizure 6.12. Any condition that may adversely affect patient safety or obscure assessment of efficacy 7. Patients receiving any of the following medications: 7.1. Monoamine oxidase inhibitors 7.2. Carbamazepine 7.3. Quinidine 7.4. Selective serotonin reuptake inhibitors 7.5. Serotonin norepinephrine reuptake inhibitors 7.6. Neuroleptics 7.7. Warfarin 7.8. Digoxin 8. Patients who have received an investigational drug within the previous month 9. Patients with a known or suspected history of drug or alcohol abuse
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| All assessments measured during the last week of treatment in each phase: 1. Neuropathic Pain Scale 2. Pain and sleep 3. Pain and disability 4. Quality of life 5. Depression inventory | — |
Primary
| Measure | Time frame |
|---|---|
| Pain intensity measured during the last week of treatment in each phase. | — |
Countries
Canada
Outcome results
None listed