Multicenter Clinical Study, Phase III, Prospective, Randomized, Double-blind, Comparative to Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Observation of adverse events related to medication. The causality of adverse events concerning the use of medication will be given after applying the Naranjo Algorythm
Study Overview
Brief Summary
To evaluate the efficacy and tolerability of Vitatonus Dexa compared with dexamethasone in the signs and symptoms of neuralgia of various origins.
Clinical study, randomized prospective and random in nature, with a patients diagnosed with neuralgia of diverse origin.
Patients will be include in sufficient quantity to achieve the minimum of 104 evaluable patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who consent to participate in the study by signing the ICF;
- •Patients of any ethnic group of both sexs aged over 18 years;
- •Patients with clinical diagnosis of neuralgia of various origins.
- •Patients who present scores on the Visual Analogue Scale (VAS) greater than or equal to 4 for PAIN.
Exclusion Criteria
- •Patients with known hypersensitivity to lidocaine and thiamine or any component of the formula;
- •Pregnant women and nursing mothers;
- •Hypertensive or cardiac patients;
- •Patients with history of ulcers in the stomach or duodenum, diabetes mellitus or severe infections;
- •Patients who use levodopa, salicylates, colchicine, aminoglycosides, chloramphenicol, anticonvusivantes or potassium supplement.
- •Patient with a history of alcohol or use illicit drugs;
Arms & Interventions
Dexamethasone and complex vitamins
Group A: Vitatonus dexa injectable:
1 ampoule intramuscularly every 3 days for 10 days.
Group B: Vitatonus DEXA tablet:
1 tablet orally every 8 hours for 10 days.
Intervention: Dexamethasone (Drug)
Dexamethasone
Group C: Dexamethasone Injectable:
1 ampoule intramuscularly every 3 days for 10 days.
Group D: Dexamethasone tablet:
1 tablet orally every 8 hours for 10 days.
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Observation of adverse events related to medication. The causality of adverse events concerning the use of medication will be given after applying the Naranjo Algorythm
Time Frame: Ten days
Secondary Outcomes
- Efficacy evaluation Likert scale and Visual Analogue(Ten days)