Polyneuropathic pain MedDRA version: 8.0 Level: LLT Classification code 10054095
Conditions
Interventions
Product Name: GRT9906
Product Code: GRT9906, GRTA9906, EM906
Pharmaceutical Form: Prolonged-release tablet
CAS Number: 187219-68-7
Current Sponsor code: GRT9906
Concentration unit: mg milligram(s)
Con
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Painful polyneuropathy of mixed origin (diabetic, idiopathic, alcoholic or drug-induced neuropathy) with symptoms present for more than six months - The pain must be distal and symmetric in the extremities and tendon reflexes must be reduced or absent - No pain increase on activity - Altered sensation distally on examination (touch; pin-prick; temperature) - Abnormal conduction (motor nerve conduction velocity, distal motor latency, motor action potential amplitude, sensory nerve conduction velocity or sensory action potential amplitude) in at least two nerves, one of them being a leg nerve - Average pain intensity of neuropathic pain over the last three days before randomization visit must be at least four points, using an 11-point NRS 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: - Known or suspected of being unable to comply with the study protocol and the use of the investigational medicinal products - Evidence or history of alcohol, medication or drug dependency during the past 12 months - Evidence or history of psychiatric illness including neurotic personality, anxiety disorder and depression needing treatment with antidepressants, severe senile dementia, Alzheimer's disease, history of seizures or suicide risk - Cancer, poor medical status (e.g. NYHA class ? 3; Child classification for hepatic impairment >A (Pugh et al, 1973); decompensated chronic obstructive pulmonary disease) or, at the discretion of the investigator, clinical signs that raise concerns about subject's suitability for the study - Subjects undergoing active treatment for cancer, are known to be infected with the HIV, hepatitis B or C, or being acutely and intensively immunosuppressed following transplantation - Creatinine higher than 1.5 x upper limit of normal range - ALT and/or AST higher than 2 x upper limit of normal range - Pregnancy or nursing mother - Clinically significant disease which in the investigator’s opinion may affect efficacy or safety assessments - HbA1c > 12% at enrolment (discretion of the investigator) - QT values of: QTcB females = 450 msec, QTcB males = 430 msec, uncorrected QT = 500 msec) at enrolment and/ or randomization - Known contraindications/hypersensitivity to opioids, tramadol, zolpidem or paracetamol or definite or suspected allergy or hypersensitivity to drugs having a similar mechanism of action as the study drug - Use of fentanyl transdermal system, buprenorphine sublingual or transdermal system with a half-life of more than 35 hours, ? 7 days prior to randomization - Use of serotonergic drugs, drugs with the potential to prolong QT interval, CYP2D6 substrates, antiepileptic drugs, antiparkinson drugs, MAO inhibitors, neuroleptics or other drugs that may lower the seizure threshold, within less than five half-life times prior to randomization at least 7 days - Use of any analgesics (incl. NSAIDs and COX2 inhibitors) other than the investigational product(s) and paracetamol as rescue medication or sedatives (with the exception of 5 mg zolpidem for a maximum of three days per week) within less than five half-life times prior to randomization at least 7 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the multiple-dose analgesic efficacy and safety of oral GRT9906 PR at 120-240 mg daily in comparison to placebo in subjects with painful polyneuropathy;Secondary Objective: - To compare the multiple-dose analgesic efficacy and safety of oral GRT9906 PR at 120-240 mg per day to tramadol PR 200-400 mg per day in subjects with painful polyneuropathy - To evaluate population PK/PD ;Primary end point(s): To demonstrate that the average pain intensity, calculated as an average of daily current pain over the last three days before the last visit per treatment period, is significantly lower after treatment with GRT9906 compared to treatment with placebo | — |
Countries
Denmark, Germany
Outcome results
None listed