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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by MDCPharma Produtos Farmaceuticos LTDA.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
MDCPharma Produtos Farmaceuticos LTDA
ClinicalTrials.gov Identifier:
NCT01295450
First received: January 19, 2011
Last updated: February 11, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Lack of Appetite
Anorexia
Drug: Apevinat BC
Drug: Vitamin Complex
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MDCPharma Produtos Farmaceuticos LTDA:

Primary Outcome Measures:
  • Evaluate the effectiveness of Apevinat BC in appetite stimulation. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Evaluate the efficacy of BC Apevinat in appetite stimulation compared to vitamins.


Secondary Outcome Measures:
  • Evaluate the tolerability of Apevinat BC in appetite stimulation. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    To evaluate the tolerability of Apevinat BC in appetite stimulation compared to vitamins.


Estimated Enrollment: 74
Study Start Date: April 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin Complex
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 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.

Other Names:
  • Apevinat BC
  • MDCPharma
Experimental: Apevinat BC

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
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.
Other Name: Polivitamin, B and C Complex.

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.

  Eligibility

Ages Eligible for Study:   7 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295450

Contacts
Contact: Anete S Grumach, Investigator 55 (11) 4993-5468 grumach@usp.br
Contact: Adriana P Albuquerque, Coordenator 55 (11) 4438-3558 adrianaalbuquerque@fmabc.br

Locations
Brazil
ABC School of Medicine Not yet recruiting
Sao Paulo, Brazil, 09060-650
Contact: Adriana P Albuquerque, Coordenator    55 (11) 4438-3558    adrianaalbuquerque@fmabc.br   
Principal Investigator: Anete S Grumach, Physician         
Sponsors and Collaborators
MDCPharma Produtos Farmaceuticos LTDA
Investigators
Principal Investigator: Joaquim CS D' Azevedo, Investigator A/Z Clinical
Principal Investigator: Felicio S Neto, Investigator Dr. Felicio Savioli Clinical
  More Information

No publications provided

Responsible Party: MDCPharma Produtos Farmaceuticos LTDA, Industry
ClinicalTrials.gov Identifier: NCT01295450     History of Changes
Other Study ID Numbers: MDC-APEVINAT-01/10
Study First Received: January 19, 2011
Last Updated: February 11, 2011
Health Authority: Brazil: ANVISA - National Health Surveilance Agency

Keywords provided by MDCPharma Produtos Farmaceuticos LTDA:
Phase III
Apevinat BC
Lack of appetite

Additional relevant MeSH terms:
Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms
Cyproheptadine
Flavin Mononucleotide
Vitamins
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Vitamin B Complex
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 26, 2014