Lack or Loss Appetite Nonorganic OriginPhase 3InappetenceNCT01283646
Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite
A Phase 3 study testing Apevitin BC and Vitamin B Complex + Vitamin C in people with Lack or Loss Appetite Nonorganic Origin, run by EMS at 3 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Lack or Loss Appetite Nonorganic Origin
- What is being tested?
- Apevitin BC and Vitamin B Complex + Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesBrazil
- Study dates
- Oct 2011to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Faculdade de Medicina do ABC
Santo André, São Paulo
Clínica A/Z
São Paulo, São Paulo
Clínica Dr. Felício Savioli
São Paulo, São Paulo
About this study
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
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.
Read the 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
- Conditions
- Lack or Loss Appetite Nonorganic Origin
- Being tested
- Apevitin BC, Vitamin B Complex + Vitamin C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apevitin BCDrug
3.5 to 5 ml 3 times a daily
Vitamin B Complex + Vitamin CDrug
3.5 to 5 ml 3 times a daily
| Study group | Role | What they receive |
|---|---|---|
| Apevitin BC | Experimental | Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily Receives: Drug: Apevitin BC |
| Vitamin B Complex + Vitamin C | Active comparator | Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily Receives: Drug: Vitamin B Complex + Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex.
Clinical evaluation of the patient's general condition. The lowest responsible will report less data about their inappetence.
Measured: 30 days
Secondary outcomes (1)
Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex
The lowest responsible will repost less data about their inappetence.Final evaluation of efficacy and tolerability.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lack or Loss Appetite Nonorganic OriginStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felipe Pinho, MD, Study director, EMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283646
- Sponsor's protocol ID
- TRPEMS0910
- Acronym
- Inappetence
- Status last verified
- Mar 2013
- First submitted
- 25 Jan 2011
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01283646
- Acronym / sponsor ID
- Inappetence / TRPEMS0910
- Conditions
- Lack or Loss Appetite Nonorganic Origin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apevitin BC | Experimental | Drug: Apevitin BCChildren (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily |
| Vitamin B Complex + Vitamin C | Active comparator | Drug: Vitamin B Complex + Vitamin CChildren (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apevitin BC3.5 to 5 ml 3 times a daily | Drug | Apevitin BC |
| Vitamin B Complex + Vitamin C3.5 to 5 ml 3 times a daily | Drug | Vitamin B Complex + Vitamin C |
Primary outcome
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.
1 secondary outcome
Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Pinho, MD study director
EMS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apevitin BC and Vitamin B Complex + Vitamin C in people with Lack or Loss Appetite Nonorganic Origin, run by EMS at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.