NeuroEPO in healthy volunteers.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the safety of the nasal administration of NeuroEPO in healthy volunteers.

Secondary indentifying numbers:

IIC RD-EC 148

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology(CIM)

Source(s) of monetary or material support:

Ministry of Public Health(MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

28/03/2013

Reference number:

05.018.13.B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

MD.Alina Díaz Machado.Fisrt degree Specialist in pharmacology

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

National Center for Toxicology(CENATOX)

Research ethics committees:

National Center for Toxicology(CENATOX), September 1 ,2012

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

10/06/2013

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Stroke

Intervention(s):

Group A: NeuroEPO 1 mg every 8 hours for 4 days by intranasal route. Each dose will be administered at two times. First applies a volume of 250 µL of NeuroEPO in each nostril and 15 minutes later, repeat the application for a final volume in each nostril of 500 µL. Group B: NeuroEPO 0.5 mg every 8 hours for 4 days by intranasal route. Each dose will be administered at two times. First applies a volume of 250 µL of NeuroEPO in each nostril and 15 minutes later, applies a volume of 250 µL of placebo (formulation without the active pharmaceutical ingredient)in each nostril. The final volume in each nostril will be 500 µl. The treatment will begin the second day of the income and will have duration of 4 days.Duration of the income :6 days

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Severity of AE (Serious, Not serious). Measuring time:daily during hospitalization. Day 14 Intensity of the AE (1 Light, 2. Moderate, 3.Severe). Measuring time:daily during hospitalization. Day 14

Key secondary outcomes:

Adverse events (AE). Measuring time:daily during hospitalization. Day 14 - Type of AE (description of the adverse event presented) - Severity of AE (Serious, Not serious) - Intensity of the AE (1 Light, 2. Moderate, 3.Severe) - Conduct (Dose diminishment, temporary interruption of treatment, permanent interruption of treatment) - Result (1.Recovery, 2.Recovery with sequels, 3.Improved, 4.Persistence, 5.Death) - Causality relationship (1.Very likely/insurance, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluable/not classifiable) Local tolerance (nasal mucous).Measuring time:daily during hospitalization. Day 14 - Signs of local toxicity (Yes, No) - Intensity (Mild, Moderate, Severe) - Reversible (Yes, No) Hemoglobin (g/l). Measuring time: at the beginning, day 5 and day 14. Hematocrit (%). Measuring time: at the beginning, day 5 and day 14. Reticulocyte count (%).Measuring time: at the beginning, day 5 and day 14. Count of leukocytes (109/L).Measuring time: at the beginning, day 5 and day 14. Platelet count (mm3).Measuring time: at the beginning, day 5 and day 14. Partial thromboplastin time (seg).Measuring time: at the beginning, day 5 and day 14. Prothrombin time (seg).Measuring time: at the beginning, day 5 and day 14. Glucose (mmol/L).Measuring time: at the beginning, day 5 and day 14. Cholesterol (mmol/L).Measuring time: at the beginning, day 5 and day 14. Creatinine (mol/L).Measuring time: at the beginning, day 5 and day 14. Transaminase (TGP) (U/L). Measuring time: at the beginning, day 5 and day 14. Transaminase (TGO) (U/L). Measuring time: at the beginning, day 5 and day 14. Gamma glutamyl transferase(GGT),) (U/L).Measuring time: at the beginning, day 5 and day 14.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

40 years

Inclusion criteria:

.Voluntary nature of the subject through the signing of informed consent. .Aged between 18 and 40 years. .Not be organic or psychological disease according to the interrogation. .Conclude successfully the physical examination.

Exclusion criteria:

.Women who are pregnant or are breastfeeding.Will be the participants in the study pregnancy test. .Volunteers with hypersensitivity to the active substance(recombinant human erythropoietin)or to any of the active substances that make up the product. .Volunteers with rhinitis of any kind. .Volunteers with the nasal septum deviation. .Volunteers with mental disorders. .Alcoholic volunteers.Will be considered alcoholics those people with more than a quarter of a bottle of rum consumption or 1 bottle of wine or three beers with one frequency greater than 2 times per week. .Presence of chronic non-communicable diseases como asma, hipertensión, diabetes mellitus o cardiopatía isquémica. .Consumption of any drug in the period between the 15 days prior to the start of the trial or during the trial. .Volunteer who has undergone more surgery during the six months prior to the start of the trial. .Having made a donation of blood during the three months prior to the start of the trial. .Participating in a clinical trial during the six months prior to the start of the study.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

1

Target sample size:

30

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Orestes

Last Name:

Santos Morales,MD.

Affiliation:

Center of Molecular Immunology (CIM), CIMAB SA

Postal Address:

206 Street No.1926 e/ 19 y 21,Atabey ,Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

537-2715057 Ext.131

Email :

orestesm@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Orestes

Last Name:

Santos Morales,MD

Affiliation:

Center of Molecular Immunology (CIM), CIMAB SA

Postal Address:

206 Street No.1926 e/ 19 y 21, Atabey ,Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

537-2715057 Ext.131

Email :

orestesm@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000157

Date of Registration in Primary Registry:

2013-06-10

Record Verification Date:

2014/01/23

Next update date:

2015/01/23

Link to the spanish version:

Click here

Versión para impresión

Ensayos Registrados

Proceso de Registro

NeuroEPO in healthy volunteers.

Acerca del RPCEC

Recursos útiles