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.

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 [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:

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:

Target sample size:

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 [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:

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 [2]

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:

Click here [3]