NCT01295450

Brief Summary

The purpose of this study is to evaluate the efficacy and tolerability of Apevinat BC compared to vitamin complex, in the treatment of lack of appetite and prevention of deficiency of B and C vitamins.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2011

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 14, 2011

Status Verified

February 1, 2011

Enrollment Period

4 months

First QC Date

January 19, 2011

Last Update Submit

February 11, 2011

Conditions

Lack of AppetiteAnorexia

Keywords

Phase IIIApevinat BCLack of appetite

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effectiveness of Apevinat BC in appetite stimulation.

    Evaluate the efficacy of BC Apevinat in appetite stimulation compared to vitamins.

    30 days

Secondary Outcomes (1)

  • Evaluate the tolerability of Apevinat BC in appetite stimulation.

    30 days

Study Arms (2)

Vitamin Complex

ACTIVE COMPARATOR

A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily.

Drug: Apevinat BC

Apevinat BC

EXPERIMENTAL

Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg). Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily.

Drug: Vitamin Complex

Interventions

Apevinat BCDRUG

Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg). Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily.

Also known as: MDCPharma
Vitamin Complex
Vitamin ComplexDRUG

A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily.

Also known as: Polivitamin, B and C Complex.
Apevinat BC

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients who presents lack of appetite;
  • Wash out 20 days after ingestion before similar drug;
  • Responsible for the least able to understand and maintain their adherence to protocol;
  • Patients of all ethnic groups of both sexes, aged 7-14 years;
  • Responsible for the minor must consent to participate in the same study, through the signing of consentiment term;
  • Responsible for the minor should be able to understand the proper use of medication;

You may not qualify if:

  • Patients with parasitic infections;
  • Patients with angle closure glaucoma or open;
  • Patients with a predisposition to urinary retention;
  • Patients with peptic ulcer or stenotic pylorus-duodenal obstruction;
  • debilitated patients or in acute asthma attack;
  • Patients who have poor appetite caused by any serious illness;
  • Patients who are taking any medications that depress the central nervous system;
  • Patients who take medication monoamine oxidase inhibitors, tricyclic antidepressants, phenothiazine, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotrophin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, Primidone, salicylates;
  • Patients with known hypersensitivity to any components of the formula;
  • Patients who are participating in another clinical trial;
  • Inability to compliance with the protocol;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ABC School of Medicine

São Paulo, São Paulo, 09060-650, Brazil

Location

MeSH Terms

Conditions

Anorexia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Joaquim CS D' Azevedo, Investigator

    A/Z Clinical

    PRINCIPAL INVESTIGATOR

  • Felicio S Neto, Investigator

    Dr. Felicio Savioli Clinical

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anete S Grumach, Investigator

CONTACT

55 (11) 4993-5468grumach@usp.br

Adriana P Albuquerque, Coordenator

CONTACT

55 (11) 4438-3558adrianaalbuquerque@fmabc.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 19, 2011

First Posted

February 14, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 14, 2011

Record last verified: 2011-02

Locations

BR(1)