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THERESA
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9 April 2013 - 3:09pm
by Webmaster
20 January 2017 - 12:05pm
by lazara
Changes to
Research ethics committees
-
"Enrique Cabrera" Clinical-Surgical Hospital, Havana
:
October 23rd 2005. "Camilo Cienfuegos" Clinical-Surgical Hospital, Sancti Spiritus
:
August 8th 2006.
+
"Enrique Cabrera" Clinical-Surgical Hospital, Havana
;
October 23rd 2005.
+
"Camilo Cienfuegos" Clinical-Surgical Hospital, Sancti Spiritus
;
August 8th 2006.
Changes to
First name
-
Dr.
Livan
Quintero Tabio
+
Livan
Changes to
Last name
-
Not entered
+
Quintero Tabio
Changes to
Health condition(s) code
-
+
Hemorrhoids
+
Rectal Diseases
+
Intestinal Diseases
+
Gastrointestinal Diseases
+
Digestive System Diseases
+
Vascular Diseases
Changes to
Medical Specialty
-
+
Specialist 2nd degree in Coloproctology
Changes to
Affiliation
-
Not entered
+
Clinical Surgical Hospital "Camilo Cienfuegos"
Changes to
Postal address
-
Not entered
+
Bartolomé Masó No. 128. corner Mirto
Changes to
Intervention code
-
+
Streptokinase
+
Suppositories
+
Administration, Rectal
Changes to
City
-
Not entered
+
Sancti Spiritus
Changes to
Country
-
Not entered
+
Cuba
Changes to
Zip Code
-
Not entered
+
60100
Changes to
Maximum age
-
No restriction
+
None
Changes to
First Name
-
Dr.
Francisco
+
Francisco
Changes to
Specialty
-
+
2nd Degree Specialist in Hygiene and Epidemiology
Changes to
City
-
Havana
City
+
Havana
Changes to
Zip Code
-
Not entered
+
6162
Changes to
First Name
-
Dr.
Francisco
+
Francisco
Changes to
Specialty
-
+
2nd Degree Specialist in Hygiene and Epidemiology
Changes to
City
-
Havana
City
+
Havana
Changes to
Zip Code
-
Not entered
+
6162
Changes to
Record Verification Date
-
2008-10-
01 20
:00
+
2017/
01
/
20
Changes to
Next update date
-
+
2018/01/20
Changes to
Issuing authority of the secondary identifying numbers
-
+
Center for Genetic Engineering and Biotechnology.
Changes to
Secondary sponsor
-
+
Not Applicable
Revision of 20 January 2017 - 12:05pm:
THERESA
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:
Treatment with recombinant Streptokinase in the acute haemorrhoidal disease.
Secondary indentifying numbers:
IG/SKO/HM/0401
Issuing authority of the secondary identifying numbers:
Center for Genetic Engineering and Biotechnology.
Primary sponsor:
Genetic and Biotechnological Engineering Center (CIGB), of Havana.
Secondary sponsor:
Not Applicable
Source(s) of monetary or material support:
Ministry of Public Health.
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 :
12/02/2006
Reference number:
265/05.034.05.B
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Livan
Last name:
Quintero Tabio
Medical Specialty :
Specialist 2nd degree in Coloproctology
Affiliation:
Clinical Surgical Hospital "Camilo Cienfuegos"
Postal address:
Bartolomé Masó No. 128. corner Mirto
City:
Sancti Spiritus
Country:
Cuba
Zip Code:
60100
Telephone:
+53-041338001
Email address:
direccion@hpss.ssp.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, "Enrique Cabrera" Clinical-Surgical Hospital, Dr. Armando Aguiar Mendoza.
Research ethics committees:
"Enrique Cabrera" Clinical-Surgical Hospital, Havana; October 23rd 2005.
"Camilo Cienfuegos" Clinical-Surgical Hospital, Sancti Spiritus; August 8th 2006.
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
21/05/2006
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:
Acute Haemorrhoidal Disease.
Health condition(s) code:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Intervention(s):
Administration of 4 suppositories of 200 000 IU of SK distributed each 6 hours.
Intervention code:
Streptokinase
Suppositories
Administration, Rectal
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):
Safety evaluation: 1.Adverse clinical events (type, duration, seriousness, result and causality relation) by means of interrogation, and general and local physical examination. Measurement time: 24 hours, 48 hours and at 10 days post-leaving. 2.Haemostasis: Haemostatic parameters (thrombin time, fibrinogen and degradation products of fibrin/fibrinogen -PDF). Measurement time: 24 and 48 hours. 3.Immunogenicity: Presence of anti-streptokinase antibodies. Measurement time: 10 days from leaving.
Key secondary outcomes:
1.Pain: measured by a visual analogous scale. 2.Œdema: evaluated by its presence or not at the direct physical examination (inspection) of the region. 3.Lesion size: indirect and objective measure of the oedema evolution. The patient was placed in decubitus prone with exposure of the anal part and measured in centimetres, at the beginning, 24 and 48 hours, the larger horizontal and vertical diameters of the lesion.
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:
None
Inclusion criteria:
1.Diagnostics of the acute haemorrhoidal illness. 2.Age equal or superior to 18 years. 3.Voluntariety of the individual by jeans of the signature of the written consent. Patients of both sexes were included.
Exclusion criteria:
1. Antecedents of intracranial haemorrhage. 2.Antecedents of cerebrovascular illness, intracranial surgery or cranial trauma < 3 months. 3.Digestive or urinary bleeding < 21 days. 4.Recent surgery < 14 days. 5.Recent serious traumatism < 4 weeks. 6.Puncture of not compressible major vases in the last 7 days. 7.Trombine time > 20 seconds or a coagulation time > 10 seconds. 8.Treatment with anticoagulant pharmaceutical products. 9.Active internal haemorrhage (<3 weeks) or other conditions where there’s important bleeding risk or it’ll be difficult to handle ought to its location. 10.Haemorrhoidal illness caused by portal hypertension. 11.Haemorrhoidal illness associated to abscesses, fistula or cancer. 12.Haemorrhoidal illness with septic or active hemorrhagic complications. 13.Administration of streptokinase in the precedent 6 months. 14.Antecedents of allergy to streptokinase or salicylates including aspirin. 15.Pregnancy or lactation. 16.Evident mental incapacity to emit the consent and act consequently with 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:
N/A: single arm study
Masking:
Open
Control group:
Uncontrolled
Study design:
Single group
Phase:
1
Target sample size:
10
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:
Francisco
Last Name:
Hernandez-Bernal
Specialty:
2nd Degree Specialist in Hygiene and Epidemiology
Affiliation:
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Postal Address:
31st Ave. between 158 and 190, Cubanacan, Playa .
City:
Havana
Country:
Cuba
Zip Code:
6162
Telephone:
(53-7)-2085887, 2087379.
Email :
hernandez.bernal@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:
Francisco
Last Name:
Hernandez-Bernal
Specialty:
2nd Degree Specialist in Hygiene and Epidemiology
Affiliation:
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Postal Address:
31st Ave. between 158 and 190, Cubanacan, Playa .
City:
Havana
Country:
Cuba
Zip Code:
6162
Telephone:
(53-7)-2085887, 2087379.
Email :
hernandez.bernal@cigb.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:
RPCEC00000021
Date of Registration in Primary Registry:
2008-10-07
Record Verification Date:
2017/01/20
Next update date:
2018/01/20
Link to the spanish version:
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