Recruiting NCT04666714
Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Praga formulation, Placebo pregabalin 75mg, Placebo Pregabalin 150mg, Pregabalin 75mg.
- Who it may be relevant to
- Registry conditions: Neuropathic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
Overview
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.
Interventions
- Drug Praga formulation
Praga formulation tablet - Other Placebo pregabalin 75mg
Placebo pregabalin 75mg tablet - Other Placebo Pregabalin 150mg
Placebo Pregabalin 150mg tablet - Drug Pregabalin 75mg
Pregabalin 75mg tablet - Drug Pregabalin 150mg
Pregabalin 150mg tablet - Other Placebo Praga formulation
Placebo Praga formulation tablet
Primary outcome measures
- Change from baseline in pain intensity. [Time frame: 3 months]
Secondary outcome measures (1)
- Incidence and severity of adverse events recorded during the study. [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Allegisa — Campinas
Identifiers
NCT: NCT04666714 · EMS1719 - PRAGA