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.

Inappetence Clinical Trial

— Apetiviton BC  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01086865
• Other study ID #: E02-CIF-APE-02-08
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 12, 2010
• Last updated: May 18, 2010
• Start date: August 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2009
• Source: Cifarma Cientifica Farmaceutica Ltda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: ANVISA - National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inappetence

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cifarma Cientifica Farmaceutica Ltda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors.		30 days	Yes
Secondary	Evaluate the tolerability of apetiviton BC compared to Petivit BC the stimulation of appetite in children, adults and seniors		30 days	Yes