EGF in bilateral symmetric diabetic neuropathy

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Actualizado por CIGB en 23/03/2020 - 4:05pm

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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:

Clinical trial with different doses of human recombinant epidermal growth factor, administered subcutaneously and perineurally, in patients with bilateral symmetric diabetic neuropathy.

Secondary indentifying numbers:

IG/FCEI/ND/1927

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, Cuba.

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 Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Carlos

Midle name:

Alberto

Last name:

Gonzalez Delgado

Medical Specialty :

2nd grade specialist in Clinical Pharmacology

Affiliation:

National Center for Toxicology (CENATOX)

Postal address:

Avenida 31 y Calle 114, Marianao

City:

Havana

País:

Cuba

Zip Code:

11400

Telephone:

+53-72743282

Email address:

eclinicos@infomed.sld.cu

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:

Havana, Institute of Neurology and Neurosurgery, Norge Santiesteban Velazquez, 2nd degree Specialist in Neurology.

Havana, "Hermanos Ameijeiras" Hospital, Yaser Estrada Napoles, 1st degree Specialist in Pathological Anatomy.

Havana, Surgical Medical Research Center, Yolanda Cruz Gomez, Master in Clinical Laboratory.

Havana, "Carlos J. Finlay" Hospital, Joan Laffita Zamora, 1st Grade Specialist in Anesthesia and Resuscitation.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

04/05/2020

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:

Bilateral symmetric diabetic neuropathy

Health condition(s) code:

Diabetic Neuropathies

Diabetes Complications

Diabetes Mellitus

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Diseases

Intervention(s):

Group I-Experimental: 8.3 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, 10 cm proximal to the internal and external ankle malleolus, 3 times per week for up to 8 weeks. Group II-Experimental: 8.3 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, perineurally before bifurcation of the sciatic nerve, 3 times per week for up to 8 weeks. Group III-Experimental: 25 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, 10 cm proximal to the internal and external ankle malleolus, 3 times per week for up to 8 weeks. Group IV-Experimental: 25 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, perineurally before bifurcation of the sciatic nerve, 3 times per week for up to 8 weeks. Group V-Experimental: 75 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, 10 cm proximal to the internal and external ankle malleolus, 3 times per week for up to 8 weeks. Group VI-Experimental: 75 µg of recombinant epidermal growth factor [EGF] administered subcutaneously, perineurally before bifurcation of the sciatic nerve, 3 times per week for up to 8 weeks.

Intervention code:

Epidermal Growth Factor

Drug Administration Routes

Injections, Subcutaneous

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):

Serious Adverse Events (SAE). They will be measured as: -SAE occurrence (Yes, No), -SAE description (name of the event), -Causality relationship (probable or definitive), -Measures taken (None, Administration of any pharmacological therapy, Addition of a therapy Non-pharmacological, Exit from the study, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event). Measurement time: three times a week for 8 weeks.

Key secondary outcomes:

Clinical response: a) Criteria of the patient about his pain (reduction or not of the parameter, in number, through the Brief Inventory of pain scale, and the MICHIGAN scale). Measurement time: on inclusion, weekly for 8 weeks. b) Pain response criteria (percentage of pain reduction according to the Mc Gill pain questionnaire). Measurement time: at inclusion, weekly for 8 weeks; c) Drug reduction criteria for neuropathic pain (number of drugs administered for pain); Measurement time: at inclusion, weekly for 8 weeks; d) motor and sensory neuroconduction of the sural and peroneal nerves (distal latency, amplitude, conduction velocity). Measurement time: on inclusion, weekly for 8 weeks. Pharmacokinetic evaluation: Pharmacokinetic profile (Area under the curve, Plasma clearance, Apparent volume of distribution at steady state, Average lifetime, Average residence time). Measurement time: After administration of the FCEhr in its first dose. Adverse clinical events not related to research products (AE). They will be measured as: - AE occurrence (Yes, No), - AE description (event name), - Intensity of the AE (mild, moderate, severe), - Causality ratio (not related, doubtful, possible), - Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit from the study, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and invariant, Worsening , Death caused by this event). Measurement time: three times a week for 8 weeks.

Selection criterias

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

Gender:

Male/Female

Minimum age:

40 years

Maximum age:

60 years

Inclusion criteria:

1) Voluntariness of the patient by granting written informed consent. 2) Diabetic patients with a diagnosis of diabetic neuropathy 2. 3) Body mass index less than or equal to 35. 4) Age between 40 and 60 years, both inclusive. 5) Glycosylated hemoglobin less than or equal to 10%. 6) Diabetes mellitus type 2 controlled or with blood glucose up to 10 mmol / L. 7) Patients with more than 6 months of pain treatment. 8) Normal values in serum protein electrophoresis 9) Normal values of T4 and TSH. 10) Normal values of vitamin B12. 11) Test for negative celiac disease.

Exclusion criteria:

1129/5000 1) Presence of infection or ulcer of the diabetic foot. 2) Presence of chronic peripheral stigmas of arterial insufficiency. 3) Normal neuroconduction parameters: between 10 and 15 microvolt amplitude. 4) Any painful condition that makes it difficult to distinguish pain from bilateral symmetric diabetic neuropathy. 5) Uncompensated or severe systemic diseases: heart disease (acute myocardial infarction in the previous 3 months, unstable angina or heart failure with edema), moderate or severe hepatic insufficiency, renal insufficiency with creatinine values greater than 200 micromol / L. 6) Other types of neuropathy and those that concur with diabetic neuropathy. 7) Hemoglobin less than 10 g / L. 8) Hypersensitivity to the product or to any of its components. 9) History of current or past malignancy. 10) Psychiatric or neurological diseases that prevent the patient from granting consent. 11) Confirmed pregnancy or women in pregnancy plan or who do not use contraceptives. 12) History of alcoholism in the last two months. 13) Impossibility of attending the planned evaluations.

Type of population:

Adults

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Uncontrolled

Study design:

Parallel

Phase:

1-2

Target sample size:

48

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:

Amaurys

Last Name:

del Rio Martin

Specialty:

1st grade specialist in Comprehensive General Medicine and Immunology.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-72085887, 72087465

Email :

amaurys.rio@cigb.edu.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:

Amaurys

Last Name:

del Río Martín

Specialty:

1st grade specialist in Comprehensive General Medicine and Immunology.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+53-72085887, 72087465

Email :

amaurys.rio@cigb.edu.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Toxicology Center

Institute of Neurology and Neurosurgery

"Hermanos Ameijeiras" Surgical Clinical Hospital

Surgical Medical Research Center

"Carlos J. Finlay" Hospital

Status of evaluation:

approved

Status of evaluation date of Ethic Committee:

28/11/2019

30/10/2019

11/11/2019

20/02/2020

28/11/2019

Postal address of Ethic Committee :

Avenida 31 y Calle 114, Marianao, La Habana, C.P:11400, Cuba

Calle 29 esquina D, Plaza, La Habana, C.P:10600, Cuba

Calle San Lazaro # 701 esq. a Padre Varela, Centro Habana, La Habana, C.P: 10400, Cuba

Calle 216 y 11b, Reparto Siboney, Playa, La Habana, C.P:12100, Cuba

Avenida 31 y Calle 114, Marianao, La Habana, C.P:11400, Cuba

Telephone:

53- 72743282

53-78381820

53- 78761210

53-78581000

53-72743000

Correo electrónico:

eclinicos@infomed.sld.cu

dirinn@infomed.sld.cu

yaser@infomed.sld.cu

ycruz@infomed.sld.cu

joan@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

0

Study completion date:

03/08/2021

Date of available results:

15/12/2021

Date of first publication:

02/05/2022

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:

RPCEC00000305

Date of Registration in Primary Registry:

23/03/2020

Record Verification Date:

2020/03/23

Next update date:

2021/03/23

Link to the spanish version:

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EGF in bilateral symmetric diabetic neuropathy

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