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
Qualifiers
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
Treatments tested in this trial
- Praga formulation
- Placebo pregabalin 75mg
- Placebo Pregabalin 150mg
- Pregabalin 75mg
- Pregabalin 150mg
- Placebo Praga formulation
Treatment groups
136 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov