Clinical trial NCT01283646: Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lack or Loss Appetite Nonorganic Origin
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex.
timeFrame: 30 days
Secondary outcomes:
measure: Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex
timeFrame: 30 days
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: SP
city: São Paulo
country: Brazil
facility: Clínica A/Z
state: SP
city: São Paulo
country: Brazil
facility: Clínica Dr. Felício Savioli
state: SP
Study officials:
affiliation: EMS
name: Felipe Pinho, MD
role: STUDY_DIRECTOR
References: