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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01283646
First received: January 25, 2011
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Lack or Loss Appetite Nonorganic Origin
 Drug: Apevitin BC
Drug: Vitamin B Complex + Vitamin C
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EMS:

Primary Outcome Measures:
  • Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Clinical evaluation of the patient's general condition. The lowest responsible will report less data about their inappetence.


Secondary Outcome Measures:
  • Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The lowest responsible will repost less data about their inappetence.Final evaluation of efficacy and tolerability.


Enrollment: 51
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283646

Locations
Brazil
Faculdade de Medicina do ABC
Santo André, SP, Brazil
Clínica Dr. Felício Savioli
São Paulo, SP, Brazil
Clínica A/Z
São Paulo, SP, Brazil
Sponsors and Collaborators
EMS
Investigators
Study Director: Felipe Pinho, MD EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01283646     History of Changes
Other Study ID Numbers: TRPEMS0910
Study First Received: January 25, 2011
Last Updated: March 1, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Ascorbic Acid
Folic Acid
Vitamins
Vitamin B Complex
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013