To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuralgia |
Drug: Dexamethasone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
- 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 ] [ Designated as safety issue: Yes ]
- Efficacy evaluation Likert scale and Visual Analogue [ Time Frame: Ten days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 104 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. |
Drug: Dexamethasone
Group A: Vitatonus DEXA injectable: 1 ampoule intramuscularly every 3 days for 10 days. Group B: Vitatonus DEXA tablets: 1 tablet orally every 8 hours for 10 days. Group C: Dexamethasone Injectable: 1 ampoule intramuscularly every 3 days for 10 days. Group D: Dexamethasone tablets: 1 tablet orally every 8 hours for 10 days. Other Names:
|
|
Active Comparator: 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. |
Drug: Dexamethasone
Group A: Vitatonus DEXA injectable: 1 ampoule intramuscularly every 3 days for 10 days. Group B: Vitatonus DEXA tablets: 1 tablet orally every 8 hours for 10 days. Group C: Dexamethasone Injectable: 1 ampoule intramuscularly every 3 days for 10 days. Group D: Dexamethasone tablets: 1 tablet orally every 8 hours for 10 days. Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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;
Contacts and Locations| Brazil | |
| Faculdade de Medicina do ABC | Not yet recruiting |
| Santo André, São Paulo, Brazil, 09060650 | |
| Contact: Rosa Hasan 55 1149935469 r.hasan@terra.com.br | |
| Principal Investigator: Rosa Hasan | |
| Principal Investigator: | Rosa Hasan | Faculdade de Medicina do ABC |
More Information
No publications provided
| Responsible Party: | Elaine Pessoa, Bunker Indústria Farmacêutica Ltda. |
| ClinicalTrials.gov Identifier: | NCT00944502 History of Changes |
| Other Study ID Numbers: | E03-BUN-VITD-02/07 |
| Study First Received: | July 22, 2009 |
| Last Updated: | July 23, 2009 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Bunker Industria Farmaceutica Ltda.:
|
Neuralgy Dexamethasone Complex Vitamins Injection Symptoms of neuralgy of various origins |
Additional relevant MeSH terms:
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013