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Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite

Information source: EMS
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lack or Loss Appetite Nonorganic Origin

Intervention: Apevitin BC (Drug); Vitamin B Complex + Vitamin C (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: EMS

Official(s) and/or principal investigator(s):
Felipe Pinho, MD, Study Director, Affiliation: EMS

Summary

Lack of appetite is one of the most common reasons for visits to pediatric clinics. The symptoms usually manifest after weaning when they are introduced into the diet of infant foods containing salt. Is normally used to cyproheptadine in conjunction with vitamins C and B and also vitamins complex.

Clinical Details

Official title: Multicenter Clinical Study, Phase III, Randomized, Double-blind, of Prospectively Evaluate the Effectiveness and Tolerability of Apevitin BC Comparing to Vitamin Complex in Appetite Stimulation

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

Primary outcome: Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex.

Secondary outcome: Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex

Detailed description: Study Design:

- Multicenter

- Phase III

- Randomized

- Double Blind

- Prospective and Comparative

- Experiment duration: 30 days

- 3 visits (day 0, day 15 and day 30)

- Increased appetite

- Adverse event

Eligibility

Minimum age: 5 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with inappetence;

- Wash out 20 days after ingestion before similar drug;

- The charge of the patient must understand and consent in writing;

- Responsible for the minor must be able to understand the study procedures, agree to

participate and give written consent. Exclusion Criteria:

- Patients with intestinal parasitoses infection;

- Patients with glaucoma open or closure angle;

- Patients with predisposition to urinary retention;

- Patients with stenosis peptic ulcer or pylorus - duodenal obstruction;

- Debilitated patients or in acute attack of asthma;

- Patients who have lass of appetite caused by any serious disease;

- Patients who make use of any drugs central nervous system depressants;

- Patients who make use of medicines monoamineoxidase inhibitors, tricyclic

antidepressants, phenothiazines, probenecid, levodopa, phenytoin, Phenobarbital, chloramphenicol, cyclosphosphamide, cyclosporine, chlorambucil,corticotropin, mercaptopurine, isoniazid , penicillin, estrogens, contraceptives, haloperidol, ipratropium, barbiturates, primidone, salicylates.

- Hypersensitivity to components of the formula

- Patients who is participating in another clinical study;

- No able to adhere to protocol;

- Any pathology or past medical condition that can interfere with this protocol.

- Other conditions deemed reasonable by the medical investigator as to the

disqualification of the individual from study participation.

Locations and Contacts

Faculdade de Medicina do ABC, Santo André, SP, Brazil

Clínica A/Z, São Paulo, SP, Brazil

Clínica Dr. Felício Savioli, São Paulo, SP, Brazil

Additional Information

Starting date: October 2011
Last updated: March 1, 2013

Page last updated: August 20, 2015

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