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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. (Apetiviton BC)

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ClinicalTrials.gov Identifier: NCT01086865
Recruitment Status : Unknown
Verified March 2009 by Cifarma Cientifica Farmaceutica Ltda.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2010
Last Update Posted : May 19, 2010
Sponsor:
Information provided by:
Cifarma Cientifica Farmaceutica Ltda

Brief 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.

Condition or disease Intervention/treatment Phase
Inappetence Drug: Apetiviton BC Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : August 2010
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : January 2011

Arm Intervention/treatment
Active Comparator: Petivit BC Drug: Apetiviton 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.

Other Name: Petivit Bc

Experimental: Apetiviton BC Drug: Apetiviton 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.

Other Name: Petivit Bc




Primary Outcome Measures :
  1. Evaluate the effectiveness of apetiviton BC compared to Petivit BC in appetite stimulation in children, adults and seniors. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Evaluate the tolerability of apetiviton BC compared to Petivit BC the stimulation of appetite in children, adults and seniors [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

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.
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Responsible Party: Sônia Silveira Braga, Cifarma Cientifica Farmaceutica Ltda
ClinicalTrials.gov Identifier: NCT01086865    
Other Study ID Numbers: E02-CIF-APE-02-08
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: May 19, 2010
Last Verified: March 2009
Keywords provided by Cifarma Cientifica Farmaceutica Ltda:
inappetence
apetiviton BC