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

Anorexia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01295450
• Other study ID #: MDC-APEVINAT-01/10
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 19, 2011
• Last updated: February 11, 2011
• Start date: April 2011
• Est. completion date: August 2011

Study information

• Verified date: February 2011
• Source: MDCPharma Produtos Farmaceuticos LTDA
• Contact: Anete S Grumach, Investigator
• Phone: 55 (11) 4993-5468
• Email: grumach[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: ANVISA - National Health Surveilance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 14 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anorexia
• Lack of Appetite

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	ABC School of Medicine	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
MDCPharma Produtos Farmaceuticos LTDA

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effectiveness of Apevinat BC in appetite stimulation.	Evaluate the efficacy of BC Apevinat in appetite stimulation compared to vitamins.	30 days	Yes
Secondary	Evaluate the tolerability of Apevinat BC in appetite stimulation.	To evaluate the tolerability of Apevinat BC in appetite stimulation compared to vitamins.	30 days	Yes