Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN. The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
138
NeuroHelp s.r.o
Olomouc, Prague, Czechia
DADO Medical s.r.o
Prague, Prague, Czechia
DADO Medical s.r.o
Říčany, Ricany, Czechia
Institute for Clinical Research and Development( IKFE-CRO GmbH BahnhofstraBe 8A)
Mainz, Germany, Germany
Bangalore Clinisearch
Bangalore, Karnataka, India
K.L.E.S Dr. Prabhakar Kore Hospital & Medical research Centre
Belagavi, Karnataka, India
Jnana Sanjeevani Medical Centre
Bangalore, Karntaka, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India
Getwell Hospital and Research Centre
Nagpur, Maharashtra, India
Jehangir Clinical development Centre Pvt Ltd
Pune, Maharashtra, India
...and 5 more locations
Mean 24-hour average pain intensity (API) score.
Time frame: Week 4
Mean night-time API Score
Time frame: 4 weeks
Patient Global Impression of Change
Time frame: 4 weeks
Clinician Global Impression of Change
Time frame: 4 weeks
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