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)

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.

Study Overview

• Status: Unknown
• Conditions: Inappetence
• Intervention / Treatment: Drug: Apetiviton BC

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 76 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Petivit BC	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.; Other Names: Petivit Bc
Experimental: Apetiviton BC	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.; Other Names: Petivit Bc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate the tolerability of apetiviton BC compared to Petivit BC the stimulation of appetite in children, adults and seniors	30 days

Collaborators and Investigators

• Sponsor: Cifarma Cientifica Farmaceutica Ltda

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): November 1, 2010
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: March 12, 2010
• First Submitted That Met QC Criteria: March 12, 2010
• First Posted (Estimate): March 15, 2010

Study Record Updates

• Last Update Posted (Estimate): May 19, 2010
• Last Update Submitted That Met QC Criteria: May 18, 2010
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: inappetence; apetiviton BC
• Other Study ID Numbers: E02-CIF-APE-02-08