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

NCT ID: NCT01283646

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-10-31

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

Conditions

Lack or Loss Appetite Nonorganic Origin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Apevitin BC

Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily

Group Type: EXPERIMENTAL

Apevitin BC

Intervention Type: DRUG

3.5 to 5 ml 3 times a daily

Vitamin B Complex + Vitamin C

Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily

Group Type: ACTIVE_COMPARATOR

Vitamin B Complex + Vitamin C

Intervention Type: DRUG

3.5 to 5 ml 3 times a daily

Interventions

Apevitin BC

3.5 to 5 ml 3 times a daily

Intervention Type: DRUG

Vitamin B Complex + Vitamin C

3.5 to 5 ml 3 times a daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felipe Pinho, MD

Role: STUDY_DIRECTOR

EMS

Locations

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Clínica A/Z

São Paulo, São Paulo, Brazil

Clínica Dr. Felício Savioli

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

TRPEMS0910

Identifier Type: -

Identifier Source: org_study_id