Neuropathic pain in patients with diabetic peripheral neuropathy
Conditions
Interventions
Product Name: RGH-896
Pharmaceutical Form: Capsule, hard
CAS Number: 496054-87-6
Current Sponsor code: RGH-96
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 18-72
Sponsors
Gedeon Richter Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males or females (18 to 70 years of age), BMI 18-37 kg/m2 with a history of neuropathic pain for a minimum of 3 months, associated with distal symmetrical diabetic neuropathy. The average pain intensity score must be = 4 on a 0-10 overall pain Lickert scale in the week prior to the screening visit and = 40 mm on the pain VAS during the baseline week prior to randomisation. The presence of neuropathy will be confirmed by- -a combined (both feet) score of = 3 on the neuropathy deficit score (vibration, pin prick, hot/cold and ankle reflexes), -elevated vibration perception threshold (> 10V) and -sural sensory nerve action potential amplitude reduced to = 8 µV. 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: Acute medical problems including infections, unstable angina, uncontrolled hypertension (BP >175 mmHg or diastolic BP >100 mmHg measured after 10 minutes supine), or evidence of recent (last 3 months) clinically significant changes on electrocardiogram, retinopathy or renal function. Current foot ulcers.Presence of clinically significant peripheral ischemia with absent pedal pulses and absence of biphasic flow on Doppler.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of a well-tolerated oral dose of RGH-896 as an analgesic compared with that of placebo for pain associated with symmetrical, distal, sensory diabetic neuropathy;Secondary Objective: To assess tolerability and safety of escalating and maintenance doses of RGH-896, efficacy compared with that of placebo with respect to the change in quality and intensity of pain, pain relief, sleep disruption and global impression of change by investigator and patient, effect on daily dosage of concomitant paracetamol, effect on allodynia and effect on quality of life, activities of daily living and profile of mood states. ;Primary end point(s): The primary endpoint will be the comparison of change from baseline in mean VAS (pain on a visual analogue scale) scores between the last 7 days on RGH-896 with that on placebo. | — |
Countries
United Kingdom
Outcome results
None listed