Clinical trial NCT01295450: Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lack of Appetite
Anorexia
Keywords: Phase III
Apevinat BC
Lack of appetite
Lead sponsor: MDCPharma Produtos Farmaceuticos LTDA
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 74
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Evaluate the effectiveness of Apevinat BC in appetite stimulation.
timeFrame: 30 days
Secondary outcomes:
measure: Evaluate the tolerability of Apevinat BC in appetite stimulation.
timeFrame: 30 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: ABC School of Medicine
Study officials:
affiliation: A/Z Clinical
name: Joaquim CS D' Azevedo, Investigator
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Felicio Savioli Clinical
name: Felicio S Neto, Investigator
role: PRINCIPAL_INVESTIGATOR
References: