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Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex

Primary Purpose

Lack of Appetite, Anorexia

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Apevinat BC
Vitamin Complex
Sponsored by
MDCPharma Produtos Farmaceuticos LTDA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lack of Appetite focused on measuring Phase III, Apevinat BC, Lack of appetite

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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;
  • Any condition that in the opinion of the investigator would prohibit the inclusion and patient compliance with the protocol.

Sites / Locations

  • ABC School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vitamin Complex

Apevinat BC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate the tolerability of Apevinat BC in appetite stimulation.
To evaluate the tolerability of Apevinat BC in appetite stimulation compared to vitamins.

Full Information

First Posted
January 19, 2011
Last Updated
February 11, 2011
Sponsor
MDCPharma Produtos Farmaceuticos LTDA
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1. Study Identification

Unique Protocol Identification Number
NCT01295450
Brief Title
Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex
Official Title
A Clinical Multicenter, Phase III, Randomized, Double-blind, Prospectively to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex in Stimulating the Appetite
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
MDCPharma Produtos Farmaceuticos LTDA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Apevinat BC presents in its formula the cyproheptadine hydrochloride, which is an antihistamine and anti-serotonin with stimulant of appetite property associated with the vitamin B complex and C, in balanced amounts. This combination is specially formulated to adequately serve patients with anorexia represented by lack of appetite or appetite diverted to diets without the necessary vitamins. For the anorexic patients that are common B and C hypovitaminosis, the use of Apevinat BC will have a synergistic and joint action to increase appetite and facilitate correction of a diet while also supplement with B and C vitamins, this association does not decreases its tolerability and safety but hits adequately the purpose of therapeutic orexigenic. The current study will compare the efficacy and tolerability of Apevinat BC to vitamin complex administered three times a day, in the prevention and treatment of lack of appetite and B and C hypovitaminosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lack of Appetite, Anorexia
Keywords
Phase III, Apevinat BC, Lack of appetite

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin Complex
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Apevinat BC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apevinat BC
Other Intervention Name(s)
MDCPharma
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin Complex
Other Intervention Name(s)
Polivitamin, B and C Complex.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the effectiveness of Apevinat BC in appetite stimulation.
Description
Evaluate the efficacy of BC Apevinat in appetite stimulation compared to vitamins.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Evaluate the tolerability of Apevinat BC in appetite stimulation.
Description
To evaluate the tolerability of Apevinat BC in appetite stimulation compared to vitamins.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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; Any condition that in the opinion of the investigator would prohibit the inclusion and patient compliance with the protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anete S Grumach, Investigator
Phone
55 (11) 4993-5468
Email
grumach@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana P Albuquerque, Coordenator
Phone
55 (11) 4438-3558
Email
adrianaalbuquerque@fmabc.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim CS D' Azevedo, Investigator
Organizational Affiliation
A/Z Clinical
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felicio S Neto, Investigator
Organizational Affiliation
Dr. Felicio Savioli Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
ABC School of Medicine
City
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana P Albuquerque, Coordenator
Phone
55 (11) 4438-3558
Email
adrianaalbuquerque@fmabc.br
First Name & Middle Initial & Last Name & Degree
Anete S Grumach, Physician

12. IPD Sharing Statement

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Study to Evaluate the Efficacy and Tolerability of Apevinat BC Compared to Vitamin Complex

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