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.

• Status: Unknown status
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cifarma Cientifica Farmaceutica Ltda

Criteria

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.