Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite (Inappetence)

• ClinicalTrials.gov Identifier: NCT01283646
• Recruitment Status: Completed
• First Posted: January 26, 2011
• Last Update Posted: February 24, 2021
• Sponsor: EMS
• Information provided by (Responsible Party): EMS

Tracking Information

• First Submitted Date: January 25, 2011
• First Posted Date: January 26, 2011
• Last Update Posted Date: February 24, 2021
• Study Start Date: October 2011
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 25, 2011)

Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex. [ Time Frame: 30 days ]

Clinical evaluation of the patient's general condition. The lowest responsible will report less data about their inappetence.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 25, 2011)

Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex [ Time Frame: 30 days ]

The lowest responsible will repost less data about their inappetence.Final evaluation of efficacy and tolerability.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite
• Official Title: Multicenter Clinical Study, Phase III, Randomized, Double-blind, of Prospectively Evaluate the Effectiveness and Tolerability of Apevitin BC Comparing to Vitamin Complex in Appetite Stimulation
• Brief Summary: Lack of appetite is one of the most common reasons for visits to pediatric clinics.The symptoms usually manifest after weaning when they are introduced into the diet of infant foods containing salt.Is normally used to cyproheptadine in conjunction with vitamins C and B and also vitamins complex.

Detailed Description

Study Design:

• Multicenter
• Phase III
• Randomized
• Double Blind
• Prospective and Comparative
• Experiment duration: 30 days
• 3 visits (day 0, day 15 and day 30)
• Increased appetite
• Adverse event

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Lack or Loss Appetite Nonorganic Origin

Intervention

• Drug: Apevitin BC
  3.5 to 5 ml 3 times a daily
• Drug: Vitamin B Complex + Vitamin C
  3.5 to 5 ml 3 times a daily

Study Arms

• Experimental: Apevitin BC
  Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily
  Intervention: Drug: Apevitin BC
• Active Comparator: Vitamin B Complex + Vitamin C
  Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily
  Intervention: Drug: Vitamin B Complex + Vitamin C

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 1, 2013): 51
• Original Estimated Enrollment (submitted: January 25, 2011): 74
• Actual Study Completion Date: October 2012
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients with inappetence;
• Wash out 20 days after ingestion before similar drug;
• The charge of the patient must understand and consent in writing;
• Responsible for the minor must be able to understand the study procedures, agree to participate and give written consent.

Exclusion Criteria:

• Patients with intestinal parasitoses infection;
• Patients with glaucoma open or closure angle;
• Patients with predisposition to urinary retention;
• Patients with stenosis peptic ulcer or pylorus - duodenal obstruction;
• Debilitated patients or in acute attack of asthma;
• Patients who have lass of appetite caused by any serious disease;
• Patients who make use of any drugs central nervous system depressants;
• Patients who make use of medicines monoamineoxidase inhibitors, tricyclic antidepressants, phenothiazines, probenecid, levodopa, phenytoin, Phenobarbital, chloramphenicol, cyclosphosphamide, cyclosporine, chlorambucil,corticotropin, mercaptopurine, isoniazid , penicillin, estrogens, contraceptives, haloperidol, ipratropium, barbiturates, primidone, salicylates.
• Hypersensitivity to components of the formula
• Patients who is participating in another clinical study;
• No able to adhere to protocol;
• Any pathology or past medical condition that can interfere with this protocol.
• Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 15 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01283646
• Other Study ID Numbers: TRPEMS0910
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: EMS
• Original Responsible Party: Felipe Pinho, MD, EMS S/A
• Current Study Sponsor: EMS
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Felipe Pinho, MD; EMS

• PRS Account: EMS
• Verification Date: March 2013