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

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

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.

Study Overview

• Status: Completed
• Conditions: Lack or Loss Appetite Nonorganic Origin
• Intervention / Treatment: Drug: Apevitin BC; Drug: Vitamin B Complex + Vitamin C

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Hematinics; Vitamins; Folic Acid; Vitamin B Complex; Ascorbic Acid
• Other Study ID Numbers: TRPEMS0910