Back to resultsEfficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
Primary Purpose
Neuropathic Pain
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Praga formulation
Placebo pregabalin 75mg
Placebo Pregabalin 150mg
Pregabalin 75mg
Pregabalin 150mg
Placebo Praga formulation
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Praga formulation
Pregabalin
Arm Description
The study is double-dummy. The participant must take pills twice a day, as follows: Morning:Placebo pregabalin tablet, oral Night: Placebo pregabalin tablet, oral plus Praga formulation,oral
The study is double-dummy. The participant must take pills twice a day, as follows: Morning:Pregabalin tablet, oral Night: Pregabalin tablet plus, oral placebo Praga formulation, oral
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04666714
Brief Title
Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Praga formulation
Arm Type
Experimental
Arm Description
The study is double-dummy. The participant must take pills twice a day, as follows:
Morning:Placebo pregabalin tablet, oral Night: Placebo pregabalin tablet, oral plus Praga formulation,oral
Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
The study is double-dummy. The participant must take pills twice a day, as follows:
Morning:Pregabalin tablet, oral Night: Pregabalin tablet plus, oral placebo Praga formulation, oral
Intervention Type
Drug
Intervention Name(s)
Praga formulation
Intervention Description
Praga formulation tablet
Intervention Type
Other
Intervention Name(s)
Placebo pregabalin 75mg
Intervention Description
Placebo pregabalin 75mg tablet
Intervention Type
Other
Intervention Name(s)
Placebo Pregabalin 150mg
Intervention Description
Placebo Pregabalin 150mg tablet
Intervention Type
Drug
Intervention Name(s)
Pregabalin 75mg
Intervention Description
Pregabalin 75mg tablet
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Intervention Description
Pregabalin 150mg tablet
Intervention Type
Other
Intervention Name(s)
Placebo Praga formulation
Intervention Description
Placebo Praga formulation tablet
Primary Outcome Measure Information:
Title
Change from baseline in pain intensity.
Description
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 months
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events recorded during the study.
Description
The incidence and severity of adverse events recorded during the study will be determined over 6 months.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monalisa FB Oliveira, MD
Phone
+551938879851
Email
pesquisa.clinica@ncfarma.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
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