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

Tracking Information
First Submitted Date ICMJE	January 25, 2011
First Posted Date ICMJE	January 26, 2011
Last Update Posted Date	March 4, 2013
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	Complete list of historical versions of study NCT01283646 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	5 Years to 15 Years (Child)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	EMS
Study Sponsor ICMJE	EMS
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