Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite | RxWiki

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

Overview[ - collapse ][ - ]

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	Lack or Loss Appetite Nonorganic Origin
Intervention	Drug: Apevitin BC Drug: Vitamin B Complex + Vitamin C
Phase	Phase 3
Sponsor	EMS
Responsible Party	EMS
ClinicalTrials.gov Identifier	NCT01283646
First Received	January 25, 2011
Last Updated	March 1, 2013
Last verified	March 2013

Tracking Information[ + expand ][ + ]

First Received Date	January 25, 2011
Last Updated Date	March 1, 2013
Start Date	October 2011
Estimated Primary Completion Date	October 2012
Current 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.
Current 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.

Descriptive Information[ + expand ][ + ]

Brief Title	Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite
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
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	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Condition	Lack or Loss Appetite Nonorganic Origin
Intervention	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 Arm (s)	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 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

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	51
Estimated Completion Date	October 2012
Estimated Primary Completion Date	May 2012
Eligibility 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.
Gender	Both
Ages	5 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT01283646
Other Study ID Numbers	TRPEMS0910
Has Data Monitoring Committee	Yes
Information Provided By	EMS
Study Sponsor	EMS
Collaborators	Not Provided
Investigators	Study Director: Felipe Pinho, MD EMS
Verification Date	March 2013

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