Last updated 10 months ago
Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
136 patients around the world
Available in Brazil
EMS
1Research sites
136Patients around the world
This study is for people with
Neuropathic Pain
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Allergisa
Recruiting
SponsorEMS
Conditions
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04666714
