InappetencePhase 3Apetiviton BCNCT01086865
Clinical Study Phase III, Randomized, Double-blind, Prospective and Comparative to Evaluate the Efficacy and Tolerability of Using APETIVITON BC Compared to Petivit BC in Appetite Stimulate.
A Phase 3 study testing Apetiviton BC in people with Inappetence, run by Cifarma Cientifica Farmaceutica Ltda.
Trial summary
Clinical study phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC in appetite stimulate in children, adults and elderly. Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Inappetence
- What is being tested?
- Apetiviton BC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jan 2011
- 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 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For both groups:
- Patients who have inappetence;
- Patients able to understand and maintain adherence to protocol;
- Wash-out 20 days after ingestion of prior similar drug;
- Patients able to understand the correct use of medication;
- Patients who consent to participate in the study by signing the inform consent;
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- Children:
- Patients of any ethnic group male and female, aged between 2 and 6 years;
- Adults:
- Patients of any ethnic group male and female, aged between 18 and 50 years;
- Female patients in childbearing age, sexually active, make pregnancy test result should be negative and, furthermore, should be using contraceptive methods such as contraception, condom, IUD and diaphragm.
- Elderly:
- Patients of any ethnic group male and female, aged between 60 and 80 years.
- Female patients in childbearing age, sexually active, make pregnancy test result should be negative and, furthermore, should be using contraceptive methods such as contraception, condom, IUD and diaphragm.
Who cannot join
- For both groups:
- Patients with glaucoma open or closure angle;
- Patients with predisposition to urinary retention;
- Patients with stenous peptic ulcer or pylorus-duodenal obstruction;
- Debilitated patients or in acute attack of asthma;
- Alcoholic;
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- Patients who have loss of appetite caused by any serious disease;
- Patients who make use of any drugs central nervous system depressants;
- Patients who make use of medicines monoaminooxidase inhibitors, tricyclic antidepressants, phenothiazines, probenecid, levodopa, phenytoin, phenobarbital, chloramphenicol, cyclophosphamide, cyclosporine, chlorambucil, corticotropin, mercaptopurine, isoniazid, penicillin, estrogens, contraceptives, haloperidol, ipatrópico, barbiturates, primidone, salicylates;
- Patients with known hypersensitivity to any components of the formula;
- Patient who is participating in another clinical study;
- No able to adhere to protocol;
- Patients who are pregnant or breastfeeding;
- Any condition that in the opinion of the investigator can impossible to include the patient's adherence to the protocol.
About this study
Clinical study phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC in appetite stimulate in children, adults and elderly.
Read the detailed description
Clinical trial phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC stimulation of appetite in children, adults and elderly. A total of 150 patients, distributed as follows:
25 patients treated children Apetiviton BC,25 patients treated children Petivit BC, (2-6 years).
25 adult patients treated with Apetiviton BC,25 adult patients treated with Petivit BC, (18-50 years.
25 elderly patients treated with Apetiviton BC,25 elderly patients treated with Petivit BC. (60-80 years.
- Conditions
- Inappetence
- Being tested
- Apetiviton BC
- Keywords
- inappetence, apetiviton BC
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apetiviton BCDrug
Also called Petivit Bc
Administer the recommended dosage preferably one hour before the main meal:
Children (2 to 6 years): 2.5 mL 3 x daily. Adults (18 to 50 years): 5 mL 3 x daily. Elderly (60 to 80 years): 5 ml 3 x daily.
| Study group | Role | What they receive |
|---|---|---|
| Petivit BC | Active comparator | Not described Receives: Drug: Apetiviton BC |
| Apetiviton BC | Experimental | Not described Receives: Drug: Apetiviton BC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors.
Measured: 30 days
Secondary outcomes (1)
Evaluate the tolerability of apetiviton BC compared to Petivit BC the stimulation of appetite in children, adults and seniors
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 posted15 Mar 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InappetenceStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cifarma Cientifica Farmaceutica Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086865
- Sponsor's protocol ID
- E02-CIF-APE-02-08
- Acronym
- Apetiviton BC
- Status last verified
- Mar 2009
- First submitted
- 12 Mar 2010
- Last updated
- 19 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Phase III, Randomized, Double-blind, Prospective and Comparative to Evaluate the Efficacy and Tolerability of Using APETIVITON BC Compared to Petivit BC in Appetite Stimulate.
- ClinicalTrials.gov ID
- NCT01086865
- Acronym / sponsor ID
- Apetiviton BC / E02-CIF-APE-02-08
- Conditions
- Inappetence
- Keywords
- inappetence, apetiviton BC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cifarma Cientifica Farmaceutica LtdaIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 15 Mar 2010 (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.
Clinical study phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC in appetite stimulate in children, adults and elderly.
Detailed description
Clinical trial phase III, randomized, double-blind, prospective, comparative non-inferiority to evaluate the efficacy and tolerability of using APETIVITON BC compared to Petivit BC stimulation of appetite in children, adults and elderly. A total of 150 patients, distributed as follows:
25 patients treated children Apetiviton BC,25 patients treated children Petivit BC, (2-6 years).
25 adult patients treated with Apetiviton BC,25 adult patients treated with Petivit BC, (18-50 years.
25 elderly patients treated with Apetiviton BC,25 elderly patients treated with Petivit BC. (60-80 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Petivit BC | Active comparator | Drug: Apetiviton BC |
| Apetiviton BC | Experimental | Drug: Apetiviton BC |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Patients who have inappetence;
- Patients able to understand and maintain adherence to protocol;
- Wash-out 20 days after ingestion of prior similar drug;
- Patients able to understand the correct use of medication;
- Patients who consent to participate in the study by signing the inform consent;
Key exclusion criteria (14 listed)
- Patients with glaucoma open or closure angle;
- Patients with predisposition to urinary retention;
- Patients with stenous peptic ulcer or pylorus-duodenal obstruction;
- Debilitated patients or in acute attack of asthma;
- Alcoholic;
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 |
|---|---|---|
| Apetiviton BCAlso: Petivit BcAdminister the recommended dosage preferably one hour before the main meal: Children (2 to 6 years): 2.5 mL 3 x daily. Adults (18 to 50 years): 5 mL 3 x daily. Elderly (60 to 80 years): 5 ml 3 x daily. | Drug | Apetiviton BC, Petivit BC |
Primary outcome
Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors.
Time frame: 30 days
1 secondary outcome
Evaluate the tolerability of apetiviton BC compared to Petivit BC the stimulation of appetite in children, adults and seniors
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apetiviton BC in people with Inappetence, run by Cifarma Cientifica Farmaceutica Ltda.
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 14 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors. (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 19 May 2010.