Lack of AppetitePhase 3NCT01295450
Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex
A Phase 3 study testing Apevinat BC and Vitamin Complex in people with Lack of Appetite and Anorexia, run by MDCPharma Produtos Farmaceuticos LTDA at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC compared to vitamin complex, in the treatment of lack of appetite and prevention of deficiency of B and C vitamins. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Lack of Appetite, Anorexia
- What is being tested?
- Apevinat BC and Vitamin Complex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2011to Aug 2011
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who presents lack of appetite;
- Wash out 20 days after ingestion before similar drug;
- Responsible for the least able to understand and maintain their adherence to protocol;
- Patients of all ethnic groups of both sexes, aged 7-14 years;
- Responsible for the minor must consent to participate in the same study, through the signing of consentiment term;
- Responsible for the minor should be able to understand the proper use of medication;
Who cannot join
- Patients with parasitic infections;
- Patients with angle closure glaucoma or open;
- Patients with a predisposition to urinary retention;
- Patients with peptic ulcer or stenotic pylorus-duodenal obstruction;
- debilitated patients or in acute asthma attack;
- Patients who have poor appetite caused by any serious illness;
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- Patients who are taking any medications that depress the central nervous system;
- Patients who take medication monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazine, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotrophin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, Primidone, salicylates;
- Patients with known hypersensitivity to any components of the formula;
- Patients who are participating in another clinical trial;
- Inability to compliance with the protocol;
- Any condition that in the opinion of the investigator would prohibit the inclusion and patient compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
ABC School of Medicine
São Paulo, São Paulo, 09060-650
Adriana P Albuquerque, Coordenator, 55 (11) 4438-3558, adrianaalbuquerque@fmabc.br
Anete S Grumach, Physician
About this study
Official title: A Clinical Multicenter, Phase III, Randomized, Double-blind, Prospectively to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex in Stimulating the Appetite
The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC compared to vitamin complex, in the treatment of lack of appetite and prevention of deficiency of B and C vitamins.
Read the detailed description
Apevinat BC presents in its formula the cyproheptadine hydrochloride, which is an antihistamine and anti-serotonin with stimulant of appetite property associated with the vitamin B complex and C, in balanced amounts.
This combination is specially formulated to adequately serve patients with anorexia represented by lack of appetite or appetite diverted to diets without the necessary vitamins. For the anorexic patients that are common B and C hypovitaminosis, the use of Apevinat BC will have a synergistic and joint action to increase appetite and facilitate correction of a diet while also supplement with B and C vitamins, this association does not decreases its tolerability and safety but hits adequately the purpose of therapeutic orexigenic.
The current study will compare the efficacy and tolerability of Apevinat BC to vitamin complex administered three times a day, in the prevention and treatment of lack of appetite and B and C hypovitaminosis.
- Conditions
- Lack of Appetite, Anorexia
- Being tested
- Apevinat BC, Vitamin Complex
- Keywords
- Phase III, Apevinat BC, Lack of appetite
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apevinat BCDrug
Also called MDCPharma
Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg).
Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily.
Vitamin ComplexDrug
Also called Polivitamin, B and C Complex.
A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin Complex | Active comparator | A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily. Receives: Drug: Apevinat BC |
| Apevinat BC | Experimental | Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg).
Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily. Receives: Drug: Vitamin Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of Apevinat BC in appetite stimulation.
Evaluate the efficacy of BC Apevinat in appetite stimulation compared to vitamins.
Measured: 30 days
Secondary outcomes (1)
Evaluate the tolerability of Apevinat BC in appetite stimulation.
To evaluate the tolerability of Apevinat BC in appetite stimulation compared to vitamins.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lack of AppetiteStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MDCPharma Produtos Farmaceuticos LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joaquim CS D' Azevedo, Investigator, Principal investigator, A/Z ClinicalFelicio S Neto, Investigator, Principal investigator, Dr. Felicio Savioli Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295450
- Sponsor's protocol ID
- MDC-APEVINAT-01/10
- Status last verified
- Feb 2011
- First submitted
- 19 Jan 2011
- Last updated
- 14 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Multicenter, Phase III, Randomized, Double-blind, Prospectively to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex in Stimulating the Appetite
- ClinicalTrials.gov ID
- NCT01295450
- Acronym / sponsor ID
- MDC-APEVINAT-01/10
- Conditions
- Lack of Appetite, Anorexia
- Keywords
- Phase III, Apevinat BC, Lack of appetite
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- MDCPharma Produtos Farmaceuticos LTDAIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 14 Feb 2011 (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.
The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC compared to vitamin complex, in the treatment of lack of appetite and prevention of deficiency of B and C vitamins.
Detailed description
Apevinat BC presents in its formula the cyproheptadine hydrochloride, which is an antihistamine and anti-serotonin with stimulant of appetite property associated with the vitamin B complex and C, in balanced amounts.
This combination is specially formulated to adequately serve patients with anorexia represented by lack of appetite or appetite diverted to diets without the necessary vitamins. For the anorexic patients that are common B and C hypovitaminosis, the use of Apevinat BC will have a synergistic and joint action to increase appetite and facilitate correction of a diet while also supplement with B and C vitamins, this association does not decreases its tolerability and safety but hits adequately the purpose of therapeutic orexigenic.
The current study will compare the efficacy and tolerability of Apevinat BC to vitamin complex administered three times a day, in the prevention and treatment of lack of appetite and B and C hypovitaminosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin Complex | Active comparator | Drug: Apevinat BCA vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily. |
| Apevinat BC | Experimental | Drug: Vitamin ComplexApevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg). Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients who presents lack of appetite;
- Wash out 20 days after ingestion before similar drug;
- Responsible for the least able to understand and maintain their adherence to protocol;
- Patients of all ethnic groups of both sexes, aged 7-14 years;
- Responsible for the minor must consent to participate in the same study, through the signing of consentiment term;
Key exclusion criteria (12 listed)
- Patients with parasitic infections;
- Patients with angle closure glaucoma or open;
- Patients with a predisposition to urinary retention;
- Patients with peptic ulcer or stenotic pylorus-duodenal obstruction;
- debilitated patients or in acute asthma attack;
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 |
|---|---|---|
| Apevinat BCAlso: MDCPharmaApevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg). Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily. | Drug | Vitamin Complex |
| Vitamin ComplexAlso: Polivitamin, B and C Complex.A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily. | Drug | Apevinat BC |
Primary outcome
Evaluate the effectiveness of Apevinat BC in appetite stimulation.
Time frame: 30 days
Evaluate the efficacy of BC Apevinat in appetite stimulation compared to vitamins.
1 secondary outcome
Evaluate the tolerability of Apevinat BC in appetite stimulation.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2011.
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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.
Joaquim CS D' Azevedo, Investigator principal investigator
A/Z Clinical
Felicio S Neto, Investigator principal investigator
Dr. Felicio Savioli Clinical
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 Apevinat BC and Vitamin Complex in people with Lack of Appetite and Anorexia, run by MDCPharma Produtos Farmaceuticos 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 6 inclusion and 12 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 14 Feb 2011. 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?
Contact Anete S Grumach, Investigator (55 (11) 4993-5468, grumach@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of Apevinat BC in appetite stimulation. (time frame: 30 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 14 Feb 2011.