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

Sponsor

EMS (Industry)

Overall Status

Completed

CT.gov ID

NCT01283646

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lack or Loss Appetite Nonorganic Origin	Drug: Apevitin BC Drug: Vitamin B Complex + Vitamin C	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

51 participants

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex. [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 [30 days]
The lowest responsible will repost less data about their inappetence.Final evaluation of efficacy and tolerability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country
1	Faculdade de Medicina do ABC	Santo André	SP	Brazil
2	Clínica A/Z	São Paulo	SP	Brazil
3	Clínica Dr. Felício Savioli	São Paulo	SP	Brazil

Sponsors and Collaborators

Investigators

Study Director: Felipe Pinho, MD, EMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EMS

ClinicalTrials.gov Identifier:

NCT01283646

Other Study ID Numbers:

TRPEMS0910

First Posted:

Jan 26, 2011

Last Update Posted:

Feb 24, 2021

Last Verified:

Mar 1, 2013

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2021