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

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ClinicalTrials.gov Identifier: NCT01283646
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):

January 25, 2011
January 26, 2011
March 4, 2013
October 2011
May 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01283646 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite
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 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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Lack or Loss Appetite Nonorganic Origin
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
October 2012
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 15 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01283646
TRPEMS0910
Yes
Not Provided
Not Provided
EMS
EMS
Not Provided
Study Director: Felipe Pinho, MD EMS
EMS
March 2013

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