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
| Tracking Information | |||||
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| First Received Date ICMJE | July 22, 2009 | ||||
| Last Updated Date | July 23, 2009 | ||||
| Start Date ICMJE | October 2009 | ||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00944502 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Efficacy evaluation Likert scale and Visual Analogue [ Time Frame: Ten days ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Neuralgia | ||||
| Intervention ICMJE | 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:
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 104 | ||||
| Estimated Completion Date | December 2009 | ||||
| Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00944502 | ||||
| Other Study ID Numbers ICMJE | E03-BUN-VITD-02/07 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Elaine Pessoa, Bunker Indústria Farmacêutica Ltda. | ||||
| Study Sponsor ICMJE | Bunker Industria Farmaceutica Ltda. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bunker Industria Farmaceutica Ltda. | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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