Neuropathic Pain
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.
Interventions
DRUGPraga formulation
Praga formulation tablet
OTHERPlacebo pregabalin 75mg
Placebo pregabalin 75mg tablet
OTHERPlacebo Pregabalin 150mg
Placebo Pregabalin 150mg tablet
DRUGPregabalin 75mg
Pregabalin 75mg tablet
DRUGPregabalin 150mg
Pregabalin 150mg tablet
OTHERPlacebo Praga formulation
Placebo Praga formulation tablet
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Participants of 18 years and older; * Diagnosis of type 2 or type 1 diabetes for at least 1 year; * No change in antidiabetic medication winthin 3 months; * Diagnosis of painful sensorimotor diabetic polyneuropathy; * Presence of at least one of the following symptoms: i. numbness in the toes, feet and / or legs; ii. paresthesias (tingling and / or neuropathic pain) in the toes, feet and / or legs. * Presence of at least one of the following signs: i. symmetrical hypoesthesia of tactile, thermal or painful sensation (s) in the distal region of the legs; ii. hypoactive or abolished achilles reflexes; * Glycated hemoglobin ≤ 11%; * Score ≥ 12 points on the LANSS pain scale (Leeds Assessment of Neuropathic Symptoms and Signs); j) Participants with moderate to severe pain, a score ≥ 4 on the numerical pain scale (0-10 points); * Participants with moderate to severe neuropathic pain who recorded in the diary a minimum of 4 of the 7 days from the period to assess the baseline pain score.
Exclusion criteria
* Known hypersensitivity to the formula components used during the clinical trial; * History of alcohol and/or substance abuse within 2 years; * Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception; * History of pernicious anemia, uncontrolled hypothyroidism, chronic hepatitis B; * HIV diagnosis; * History of neurological disorder unrelated to diabetic neuropathy; * Non-responders to previous pregabalin treatment; * High variability in the baseline pain score; * Other conditions that may alter the sensitivity in the affected dermatome or in the area involved in neuropathic pain that may confuse pain assessment; * Severe psychiatric condition; * Cognitive decline that affect the participant from correctly answering the scales and questionnaires; * Clinically relevant cardiac abnormalities, which at the researcher's discretion represent a risk to participation in the trial; * Participant who has amputated lower limb due to complications from diabetes; * Renal failure, defined by the estimated glomerular filtration rate \[eGFR\] \<60 mL / min / 1.73 m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain intensity. | 3 months | The change in pain intensity from baseline after 3 months of treatment will be scored by Numerical Rating Scale from 0 to 10 points, with 0 = no pain and 10 = worst possible pain, recorded in a participant diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events recorded during the study. | 6 months | The incidence and severity of adverse events recorded during the study will be determined over 6 months. |
Countries
Brazil
Contacts
Primary ContactMonalisa FB Oliveira, MD
Outcome results
None listed