Clinical Study Phase III, Randomized, Double-blind, Prospective and Comparative to Evaluate the Efficacy and Tolerability of Using APETIVITON BC Compared to Petivit BC in Appetite Stimulate.

Phase 3

• Conditions: Inappetence
• Interventions: Drug: Apetiviton BC

• Registration Number: NCT01086865
• Lead Sponsor: Cifarma Cientifica Farmaceutica Ltda

Brief Summary

Clinical study phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC in appetite stimulate in children, adults and elderly.

Detailed Description

Clinical trial phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC stimulation of appetite in children, adults and elderly. A total of 150 patients, distributed as follows:

25 patients treated children Apetiviton BC,25 patients treated children Petivit BC, (2-6 years).

25 adult patients treated with Apetiviton BC,25 adult patients treated with Petivit BC, (18-50 years.

25 elderly patients treated with Apetiviton BC,25 elderly patients treated with Petivit BC. (60-80 years.

Study Timeline

• Status Verified: 2009-03
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Last Update Submitted: 2010-05-18
• Last Update Posted: 2010-05-19
• Study Start: 2010-08
• Primary Completion: 2010-11
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

For both groups:

• Patients who have inappetence;
• Patients able to understand and maintain adherence to protocol;
• Wash-out 20 days after ingestion of prior similar drug;
• Patients able to understand the correct use of medication;
• Patients who consent to participate in the study by signing the inform consent;

Children:

• Patients of any ethnic group male and female, aged between 2 and 6 years;

Adults:

• Patients of any ethnic group male and female, aged between 18 and 50 years;
• Female patients in childbearing age, sexually active, make pregnancy test result should be negative and, furthermore, should be using contraceptive methods such as contraception, condom, IUD and diaphragm.

Elderly:

• Patients of any ethnic group male and female, aged between 60 and 80 years.
• Female patients in childbearing age, sexually active, make pregnancy test result should be negative and, furthermore, should be using contraceptive methods such as contraception, condom, IUD and diaphragm.

Exclusion Criteria

For both groups:

• Patients with glaucoma open or closure angle;
• Patients with predisposition to urinary retention;
• Patients with stenous peptic ulcer or pylorus-duodenal obstruction;
• Debilitated patients or in acute attack of asthma;
• Alcoholic;
• Patients who have loss of appetite caused by any serious disease;
• Patients who make use of any drugs central nervous system depressants;
• Patients who make use of medicines monoaminooxidase inhibitors, tricyclic antidepressants, phenothiazines, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotropin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, primidone, salicylates;
• Patients with known hypersensitivity to any components of the formula;
• Patient who is participating in another clinical study;
• No able to adhere to protocol;
• Patients who are pregnant or breastfeeding;
• Any condition that in the opinion of the investigator can impossible to include the patient's adherence to the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Petivit BC	Apetiviton BC	-
Apetiviton BC	Apetiviton BC	-

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors.	30 days

Secondary Outcome Measures

Name	Time	Method
Evaluate the tolerability of apetiviton BC compared to Petivit BC the stimulation of appetite in children, adults and seniors	30 days