Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite (Inappetence)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Lack of appetite is one of the most common reasons for visits to pediatric clinics.The symptoms usually manifest after weaning when they are introduced into the diet of infant foods containing salt.Is normally used to cyproheptadine in conjunction with vitamins C and B and also vitamins complex.

Condition or disease	Intervention/treatment	Phase
Lack or Loss Appetite Nonorganic Origin	Drug: Apevitin BC; Drug: Vitamin B Complex + Vitamin C	Phase 3

Detailed Description:

Study Design:

• Multicenter
• Phase III
• Randomized
• Double Blind
• Prospective and Comparative
• Experiment duration: 30 days
• 3 visits (day 0, day 15 and day 30)
• Increased appetite
• Adverse event

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	51 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Multicenter Clinical Study, Phase III, Randomized, Double-blind, of Prospectively Evaluate the Effectiveness and Tolerability of Apevitin BC Comparing to Vitamin Complex in Appetite Stimulation
Study Start Date :	October 2011
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	October 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Apevitin BC; Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily	Drug: Apevitin BC; 3.5 to 5 ml 3 times a daily
Active Comparator: Vitamin B Complex + Vitamin C; Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily	Drug: Vitamin B Complex + Vitamin C; 3.5 to 5 ml 3 times a daily

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex. [ Time Frame: 30 days ]
   Clinical evaluation of the patient's general condition. The lowest responsible will report less data about their inappetence.

Secondary Outcome Measures :

1. Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex [ Time Frame: 30 days ]
   The lowest responsible will repost less data about their inappetence.Final evaluation of efficacy and tolerability.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	5 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Patients with inappetence;
• Wash out 20 days after ingestion before similar drug;
• The charge of the patient must understand and consent in writing;
• Responsible for the minor must be able to understand the study procedures, agree to participate and give written consent.

Exclusion Criteria:

• Patients with intestinal parasitoses infection;
• Patients with glaucoma open or closure angle;
• Patients with predisposition to urinary retention;
• Patients with stenosis peptic ulcer or pylorus - duodenal obstruction;
• Debilitated patients or in acute attack of asthma;
• Patients who have lass of appetite caused by any serious disease;
• Patients who make use of any drugs central nervous system depressants;
• Patients who make use of medicines monoamineoxidase inhibitors, tricyclic antidepressants, phenothiazines, probenecid, levodopa, phenytoin, Phenobarbital, chloramphenicol, cyclosphosphamide, cyclosporine, chlorambucil,corticotropin, mercaptopurine, isoniazid , penicillin, estrogens, contraceptives, haloperidol, ipratropium, barbiturates, primidone, salicylates.
• Hypersensitivity to components of the formula
• Patients who is participating in another clinical study;
• No able to adhere to protocol;
• Any pathology or past medical condition that can interfere with this protocol.
• Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Brazil
Faculdade de Medicina do ABC
Santo André, SP, Brazil
Clínica A/Z
São Paulo, SP, Brazil
Clínica Dr. Felício Savioli
São Paulo, SP, Brazil

Sponsors and Collaborators

EMS

Investigators

Study Director:	Felipe Pinho, MD	EMS

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	EMS
ClinicalTrials.gov Identifier:	NCT01283646 History of Changes
Other Study ID Numbers:	TRPEMS0910
First Posted:	January 26, 2011
Last Update Posted:	March 4, 2013
Last Verified:	March 2013

Additional relevant MeSH terms:

Vitamins; Ascorbic Acid; Folic Acid; Vitamin B Complex; Micronutrients; Growth Substances	Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Hematinics