NCT01295450

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: MDCPharma Produtos Farmaceuticos LTDA · Industry
• Sex: All
• Age: 7 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lack of Appetite
• Anorexia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-02-14
• Last updated: 2011-02-14

Locations

1 site across 1 country: Brazil