Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
ConditionNeuropathic Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMS
About this trial
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Praga formulation
DrugPraga formulation tablet
Placebo pregabalin 75mg
Other interventionPlacebo pregabalin 75mg tablet
Placebo Pregabalin 150mg
Other interventionPlacebo Pregabalin 150mg tablet
Pregabalin 75mg
DrugPregabalin 75mg tablet
Pregabalin 150mg
DrugPregabalin 150mg tablet
Placebo Praga formulation
Other interventionPlacebo Praga formulation tablet
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: Praga formulationExperimental treatment 3 interventions
Group B: PregabalinActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in pain intensity.
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.
Time frame
3 monthsSecondary outcomes
1
Incidence and severity of adverse events recorded during the study.
The incidence and severity of adverse events recorded during the study will be determined over 6 months.
Time frame
6 months Source ClinicalTrials.gov