Clinical trial NCT01086865: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Inappetence
Keywords: inappetence
apetiviton BC
Lead sponsor: Cifarma Cientifica Farmaceutica Ltda
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors.
timeFrame: 30 days
Secondary outcomes:
measure: Evaluate the tolerability of apetiviton BC compared to Petivit BC the stimulation of appetite in children, adults and seniors
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: