D004 vs terazosin

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.

Acronym of Public Title:

D4T

Scientific title:

Comparative study of medium-term effects of D-004 and terazosin in patients with benign prostatic hyperplasia

Secondary indentifying numbers:

D004-07

Issuing authority of the secondary identifying numbers:

Centre of Natural Products/National Centre for Scientifc Research

Source(s) of monetary or material support:

National Center for Scientific Research BioCubaFarma Central Account

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:

Raul

Last name:

Guzman Mederos

Medical Specialty :

Specialist of 2nd degree in Urology

Affiliation:

Dr. Salvador Allende Hospital

Postal address:

Czda.del Cerro No.1551, Cerro

City:

Havana

Country:

Cuba

Zip Code:

12000

Telephone:

+53-78705590

Email address:

raul.guzman@infomed.sld.cu [1]

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:

Not applicable

Research ethics committees:

"Dr. Salvador Allende" hospital, April 21th, 2016

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/01/2017

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:

Benign Prostatic Hyperplasia

Health condition(s) code:

Prostatic Hyperplasia

Prostatic Diseases

Genital Diseases, Male

Male Urogenital Diseases

Health condition keyword:

Lower urinary tract symptoms

Intervention(s):

Group I (Experimental): D-004 (code research) 1 softgel capsules (320 mg) daily, by oral route for 6 months. Group II (Control): Terazosin 1 tablet (5 mg) daily, by oral route for 6 months

Intervention code:

Adrenergic alpha-Antagonists

Fatty Acids

Plant Extracts

Administration, Oral

Tablets

Capsules

Intervention keyword:

Terazosin,

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):

Lower Urinary Tract Symptoms (evaluated by International Prostate Symptom Score: IPSS: Mild 1-7, Moderate 8-18, Severe 19-35). Measuring time: at baseline, and at 2, 4 and 6 months.

Key secondary outcomes:

Prostate size (determined by transrectal ultrasound-cm). Measuring time: at baseline, 6 months after treatment Retention volume (in mm, determined by transrectal ultrasound). Measuring time: at baseline, 6 months after treatment Symptoms relief (subjective assessment of symptoms: no changes, better, worse) Measuring time: 6 months after treatment Physical exam (Weigth (kg), Blood presure (mm Hg), Cardiac frequency (Pulse por minute)). Measuring time: at baseline, and 2,4 and 6 months Hematologic parameters (hemoglobin (g / dL), hematocrit (%), leukocyte count (cells x 10 9 / L), red blood cells (cells x 10 12 / L), platelets (cells x 10 9 / L)). Measuring time: at baseline and 6 months. Blood chemistry parameters (Alanine amino transferase (ALT) (U/L), Aspartate aminotransferase (AST) (U/L), Glucose (mmol/L), Creatinine (mmol/L), PCR (mg/L)). Measuring time: at baseline and 6 months. Prostate-Specific Antigen test (PSA, ng/mL). Measuring time: at baseline and 6 months. Adverse Events (AE). Measuring time: 2, 4 y 6 months of treatment. The AE will measure like: - Description of the AE (name of the event) - Intensity of AE (Mild, Moderate, Severe) - Causality relationship (WHO scale- Very probable, Probable, Possible, Remote, Not related, Unknown)

Selection criterias

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

Gender:

Male

Minimum age:

50 years

Maximum age:

80 years

Inclusion criteria:

1. Patients >= 50 years old <=80 years old 2. Informed consent 3. IPSS score between >=7, < 19 4. Enlarged prostate checked by rectal examination

Exclusion criteria:

1. Prostate Cancer. 2. Prior urological surgery. 3. Urinary retention. 4. Urinary tract infection. 5. Criteria to be catheterized in next 3 months. 6. PSA> 5 ng / mL . 7. Acute myocardial infarction, stroke, transient ischemic attack or major surgery within 6 months previous. 8. History of heart failure. 9. History of hepatic failure. 10. Blood Pressure > 180/110 mm Hg. 11. Diagnosed neoplasias. 12. Treatment with alpha 1 adrenergic antagonists, inhibitors of 5-alpha reductase, androgens,antiandrogens, cholinergics, anticholinergics,steroids and/or phytotherapy for BPH in 6 months prior study. 13. Alcoholism. 14. Psychiatric problems that limit its response to IPSS. 15. Common history of drug allergy or any other condition that affects patient´s health and life during the study.

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:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

100

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:

Julio

Middle Name:

Cesar

Last Name:

Fernandez Travieso

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Centre of Natural Products/National Centre for Scientif Research

Postal Address:

Av. 25 and 158, Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

10600

Telephone:

(53)72085834

Email :

julio.fernandez@cnic.edu.cu [2]

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:

Sarahi

Last Name:

Castaño Mendoza

Specialty:

PhD in Pharmaceutical Sciences

Affiliation:

Centre of Natural Products/National Centre for Scientific Research

Postal Address:

198 / 19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

(53)72711654

Email :

sarahi.mendoza@cnic.edu.cu [3]

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:

RPCEC00000217

Date of Registration in Primary Registry:

30/09/2016

Record Verification Date:

2016/09/30

Next update date:

2017/09/30

Link to the spanish version:

Click here [4]