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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:
ClinicalTrials.gov Identifier:
NCT01283646
First Posted: January 26, 2011
Last Update Posted: March 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
EMS
  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
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

Resource links provided by NLM:


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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283646


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

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01283646     History of Changes
Other Study ID Numbers: TRPEMS0910
First Submitted: January 25, 2011
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