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. (Apetiviton BC)

Cifarma

Status and phase

Unknown

Phase 3

Conditions

Inappetence

Treatments

Drug: Apetiviton BC

Study type

Interventional

Funder types

Industry

Identifiers

NCT01086865

E02-CIF-APE-02-08

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

2 to 80 years old

Volunteers

No Healthy Volunteers

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.