Revisions for D-004 in patients with Bening Prostatic Hyperplasia | Registro Público Cubano de Ensayos Clínicos

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Revision of 27 May 2016 - 2:24pm:

D-004 in patients with Bening Prostatic Hyperplasia

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:

Comparative study of medium-term effects of D-004 and Saw palmetto (320 mg / d) in patients with benign prostatic hyperplasia (BPH)

Secondary indentifying numbers:

D004-06, Natural Products Center (CPN)

Issuing authority of the secondary identifying numbers:

Natural Products Center (CPN)

Source(s) of monetary or material support:

Scientific Pole Central Account (CUC) Natural Products Center/ National Center for Scientific Research (CUP)

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:

Under Review

Principal investigator

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

First name:

Dr. Raúl Guzmán, MD, Second degree Specialist in Urology

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

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:

Not applicable

Research ethics committees:

Ethics Committee of Dr. Salvador Allende Hospital, 27/03/2012

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

02/09/2013

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:

Benign Prostatic Hyperplasia

Intervention(s):

Study group (D-004 (code research)): 1 softgel capsules (320 mg) daily, by oral route for 6 months. Control group (Saw palmetto): 1 softgel capsules (320 mg) daily, by oral route for 6 months

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):

International Prostate Symptom Score (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 (in cm, determined by transrectal ultrasound). 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 biochemical parameters (alanine amino transferase (ALT) (U / L), aspartate aminotransferase (AST) (U / L), glucose (mmol / L), creatinine (mmol / L), total cholesterol (mmol / L) , Triglycerides (mmol / L), LDL-C (mmol / L), HDL-C (mmol / L)). Measuring time: at baseline and 6 months. PSA test (PSA, ng/mL). Measuring time: at baseline and 6 months. Adverse Events (AE). Measuring time: 2, 4 y 6 months of treatment Description of the AE (name of the event) Intensity of AE(Mild, Moderate, Severe) 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:

N/A (No limit)

Inclusion criteria:

1. Patients with 50 years old or older 2. Informed consent 3. IPSS score between 7 and 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. Other 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:

Double Blind

Control group:

Active

Study design:

Parallel

Phase:

3

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:

Sarahi

Last Name:

Mendoza Castanno

Affiliation:

Natural Products Center

Postal Address:

198 st / 19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

(537)2714225-109 (537)2714238

Email :

sarahi.mendoza@cnic.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:

Rosa

Last Name:

Mas Ferreiro

Affiliation:

Natural Products Center

Postal Address:

198 st / 19 and 21, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

(537)2731522

Email :

clinica@cnic.edu.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:

RPCEC00000138

Date of Registration in Primary Registry:

2013-01-04

Record Verification Date:

2016/05/27

Next update date:

2017/05/27

Link to the spanish version:

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D-004 in patients with Bening Prostatic Hyperplasia

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