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Status unknownNCT01086865Apetiviton BCUpdated May 19, 2010

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 interventional study of Apetiviton BC in Inappetence, sponsored by Cifarma Cientifica Farmaceutica Ltda. Status unknown. Open to participants aged 2 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-05-19.

Sponsored by Cifarma Cientifica Farmaceutica Ltda · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
2 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Inappetence

Keywords

  • inappetence
  • apetiviton BC
03

In context

Lead sponsor

This is the only study on the registry with Cifarma Cientifica Farmaceutica Ltda as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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;

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.

Exclusion criteria

Exclusion Criteria:

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;
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Petivit BC

    Drug: Apetiviton BC

  • Experimental
    Apetiviton BC

    Drug: Apetiviton BC

Interventions

  • DrugApetiviton 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.

    Also known as: Petivit Bc

06

What researchers measure

Primary outcomes

  1. Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors.

    Time frame: 30 days

Secondary outcomes

  1. Evaluate the tolerability of apetiviton BC compared to Petivit BC the stimulation of appetite in children, adults and seniors

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01086865
Lead sponsor
Cifarma Cientifica Farmaceutica Ltda
First posted
Mar 15, 2010
Start date
Aug 2010
Primary completion
Nov 2010 (estimated)
Completion
Jan 2011 (estimated)
Last update
May 19, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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