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.

NCT ID: NCT01086865

Last Updated: 2010-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-01-31

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.

Conditions

Inappetence

Study Design

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

Study Groups

Petivit BC

Group Type: ACTIVE_COMPARATOR

Apetiviton BC

Intervention Type: DRUG

Administer the recommended dosage preferably one hour before the main meal:

Children (2 to 6 years): 2.5 mL 3 x daily. Adults (18 to 50 years): 5 mL 3 x daily. Elderly (60 to 80 years): 5 ml 3 x daily.

Apetiviton BC

Group Type: EXPERIMENTAL

Apetiviton BC

Intervention Type: DRUG

Administer the recommended dosage preferably one hour before the main meal:

Children (2 to 6 years): 2.5 mL 3 x daily. Adults (18 to 50 years): 5 mL 3 x daily. Elderly (60 to 80 years): 5 ml 3 x daily.

Interventions

Apetiviton BC

Administer the recommended dosage preferably one hour before the main meal:

Children (2 to 6 years): 2.5 mL 3 x daily. Adults (18 to 50 years): 5 mL 3 x daily. Elderly (60 to 80 years): 5 ml 3 x daily.

Intervention Type: DRUG

Other Intervention Names

Petivit Bc

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cifarma Cientifica Farmaceutica Ltda

INDUSTRY

Sponsor Role: lead

Responsible Party

Cifarma Cientifica Farmaceutica Ltda

Other Identifiers

E02-CIF-APE-02-08

Identifier Type: -

Identifier Source: org_study_id