Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex

A Clinical Multicenter, Phase III, Randomized, Double-blind, Prospectively to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex in Stimulating the Appetite

The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC compared to vitamin complex, in the treatment of lack of appetite and prevention of deficiency of B and C vitamins.

Study Overview

• Status: Unknown
• Conditions: Anorexia; Lack of Appetite
• Intervention / Treatment: Drug: Apevinat BC; Drug: Vitamin Complex

Detailed Description

Apevinat BC presents in its formula the cyproheptadine hydrochloride, which is an antihistamine and anti-serotonin with stimulant of appetite property associated with the vitamin B complex and C, in balanced amounts.

This combination is specially formulated to adequately serve patients with anorexia represented by lack of appetite or appetite diverted to diets without the necessary vitamins. For the anorexic patients that are common B and C hypovitaminosis, the use of Apevinat BC will have a synergistic and joint action to increase appetite and facilitate correction of a diet while also supplement with B and C vitamins, this association does not decreases its tolerability and safety but hits adequately the purpose of therapeutic orexigenic.

The current study will compare the efficacy and tolerability of Apevinat BC to vitamin complex administered three times a day, in the prevention and treatment of lack of appetite and B and C hypovitaminosis.

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anete S Grumach, Investigator; Phone Number: 55 (11) 4993-5468; Email: grumach@usp.br
• Study Contact Backup: Name: Adriana P Albuquerque, Coordenator; Phone Number: 55 (11) 4438-3558; Email: adrianaalbuquerque@fmabc.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 09060-650
    • ABC School of Medicine
    • Contact: Adriana P Albuquerque, Coordenator; Phone Number: 55 (11) 4438-3558; Email: adrianaalbuquerque@fmabc.br
    • Principal Investigator: Anete S Grumach, Physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who presents lack of appetite;
• Wash out 20 days after ingestion before similar drug;
• Responsible for the least able to understand and maintain their adherence to protocol;
• Patients of all ethnic groups of both sexes, aged 7-14 years;
• Responsible for the minor must consent to participate in the same study, through the signing of consentiment term;
• Responsible for the minor should be able to understand the proper use of medication;

Exclusion Criteria:

• Patients with parasitic infections;
• Patients with angle closure glaucoma or open;
• Patients with a predisposition to urinary retention;
• Patients with peptic ulcer or stenotic pylorus-duodenal obstruction;
• debilitated patients or in acute asthma attack;
• Patients who have poor appetite caused by any serious illness;
• Patients who are taking any medications that depress the central nervous system;
• Patients who take medication monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazine, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotrophin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, Primidone, salicylates;
• Patients with known hypersensitivity to any components of the formula;
• Patients who are participating in another clinical trial;
• Inability to compliance with the protocol;
• Any condition that in the opinion of the investigator would prohibit the inclusion and patient compliance with the protocol.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin Complex; A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily.	Drug: Apevinat BC; Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg). Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily.; Other Names: MDCPharma
Experimental: Apevinat BC; Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg). Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily.	Drug: Vitamin Complex; A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily.; Other Names: Polivitamin, B and C Complex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of Apevinat BC in appetite stimulation.	Evaluate the efficacy of BC Apevinat in appetite stimulation compared to vitamins.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the tolerability of Apevinat BC in appetite stimulation.	To evaluate the tolerability of Apevinat BC in appetite stimulation compared to vitamins.	30 days

Collaborators and Investigators

• Sponsor: MDCPharma Produtos Farmaceuticos LTDA
• Investigators: Principal Investigator: Joaquim CS D' Azevedo, Investigator, A/Z Clinical; Principal Investigator: Felicio S Neto, Investigator, Dr. Felicio Savioli Clinical

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): August 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: February 11, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 14, 2011
• Last Update Submitted That Met QC Criteria: February 11, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Phase III; Apevinat BC; Lack of appetite
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Anorexia; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: MDC-APEVINAT-01/10