Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite (Inappetence)
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ClinicalTrials.gov Identifier: NCT01283646 |
Recruitment Status :
Completed
First Posted : January 26, 2011
Last Update Posted : February 24, 2021
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Sponsor:
EMS
Information provided by (Responsible Party):
EMS
Tracking Information | ||||
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First Submitted Date ICMJE | January 25, 2011 | |||
First Posted Date ICMJE | January 26, 2011 | |||
Last Update Posted Date | February 24, 2021 | |||
Study Start Date ICMJE | October 2011 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite | |||
Official Title ICMJE | 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:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Lack or Loss Appetite Nonorganic Origin | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
51 | |||
Original Estimated Enrollment ICMJE |
74 | |||
Actual Study Completion Date ICMJE | October 2012 | |||
Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 5 Years to 15 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01283646 | |||
Other Study ID Numbers ICMJE | TRPEMS0910 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | EMS | |||
Original Responsible Party | Felipe Pinho, MD, EMS S/A | |||
Current Study Sponsor ICMJE | EMS | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | EMS | |||
Verification Date | March 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |