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

Lack or Loss Appetite Nonorganic Origin Clinical Trial

— Inappetence  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283646
• Other study ID #: TRPEMS0910
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lack or Loss Appetite Nonorganic Origin

Intervention

Drug:
• Apevitin BC
3.5 to 5 ml 3 times a daily
• Vitamin B Complex + Vitamin C
3.5 to 5 ml 3 times a daily

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	SP
Brazil	Clínica A/Z	São Paulo	SP
Brazil	Clínica Dr. Felício Savioli	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex.	Clinical evaluation of the patient's general condition. The lowest responsible will report less data about their inappetence.	30 days
Secondary	Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex	The lowest responsible will repost less data about their inappetence.Final evaluation of efficacy and tolerability.	30 days