NeuralgiaPhase 3NCT00944502
To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins
A Phase 3 study testing Dexamethasone in people with Neuralgia, run by Bunker Industria Farmaceutica Ltda. at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060650
Rosa Hasan, 55 1149935469, r.hasan@terra.com.br
Rosa Hasan
About this study
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
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.
- Conditions
- Neuralgia
- Being tested
- Dexamethasone
- Keywords
- Neuralgy, Dexamethasone, Complex Vitamins, Injection, Symptoms of neuralgy of various origins
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Vitatonus dexa tablest, Vitatonus Dexa Injectable
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone and complex vitamins | Experimental | 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. Receives: Drug: Dexamethasone |
| Dexamethasone | Active comparator | 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. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Ten days
Secondary outcomes (1)
Efficacy evaluation Likert scale and Visual Analogue
Measured: Ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bunker Industria Farmaceutica Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rosa Hasan, Principal investigator, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944502
- Sponsor's protocol ID
- E03-BUN-VITD-02/07
- Status last verified
- Jul 2009
- First submitted
- 22 Jul 2009
- Last updated
- 24 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00944502
- Acronym / sponsor ID
- E03-BUN-VITD-02/07
- Conditions
- Neuralgia
- Keywords
- Neuralgy, Dexamethasone, Complex Vitamins, Injection, Symptoms of neuralgy of various origins
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Bunker Industria Farmaceutica Ltda.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone and complex vitamins | Experimental | Drug: DexamethasoneGroup 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. |
| Dexamethasone | Active comparator | Drug: DexamethasoneGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Vitatonus dexa tablest, Vitatonus Dexa InjectableGroup 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. | Drug | Dexamethasone, Dexamethasone and complex vitamins |
Primary outcome
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
1 secondary outcome
Efficacy evaluation Likert scale and Visual Analogue
Time frame: Ten days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Hasan principal investigator
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Neuralgia, run by Bunker Industria Farmaceutica Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2009.