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Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex

Information source: MDCPharma Produtos Farmaceuticos LTDA
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lack of Appetite; Anorexia

Intervention: Apevinat BC (Drug); Vitamin Complex (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: MDCPharma Produtos Farmaceuticos LTDA

Official(s) and/or principal investigator(s):
Joaquim CS D' Azevedo, Investigator, Principal Investigator, Affiliation: A/Z Clinical
Felicio S Neto, Investigator, Principal Investigator, Affiliation: Dr. Felicio Savioli Clinical

Overall contact:
Anete S Grumach, Investigator, Phone: 55 (11) 4993-5468, Email: grumach@usp.br

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Evaluate the effectiveness of Apevinat BC in appetite stimulation.

Secondary outcome: Evaluate the tolerability of Apevinat BC in appetite stimulation.

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

Minimum age: 7 Years. Maximum age: 14 Years. Gender(s): Both.

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.

Locations and Contacts

Anete S Grumach, Investigator, Phone: 55 (11) 4993-5468, Email: grumach@usp.br

ABC School of Medicine, Sao Paulo 09060-650, Brazil; Not yet recruiting
Adriana P Albuquerque, Coordenator, Phone: 55 (11) 4438-3558, Email: adrianaalbuquerque@fmabc.br
Anete S Grumach, Physician, Principal Investigator
Additional Information

Starting date: April 2011
Last updated: February 11, 2011

Page last updated: August 20, 2015

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