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

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.
 
ClinicalTrials.gov Identifier: NCT01283646
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
EMS

Tracking Information
First Submitted Date  ICMJE January 25, 2011
First Posted Date  ICMJE January 26, 2011
Last Update Posted Date February 24, 2021
Study Start Date  ICMJE October 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lack or Loss Appetite Nonorganic Origin
Intervention  ICMJE
  • Drug: Apevitin BC
    3.5 to 5 ml 3 times a daily
  • Drug: Vitamin B Complex + Vitamin C
    3.5 to 5 ml 3 times a daily
Study Arms  ICMJE
  • 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
    Intervention: Drug: Apevitin BC
  • 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
    Intervention: Drug: Vitamin B Complex + Vitamin C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2013)
51
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2011)
74
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01283646
Other Study ID Numbers  ICMJE TRPEMS0910
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party EMS
Original Responsible Party Felipe Pinho, MD, EMS S/A
Current Study Sponsor  ICMJE EMS
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Felipe Pinho, MD EMS
PRS Account EMS
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP