THERESA-2 Study

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:

“Efficacy and safety of the suppository of Recombinant Streptokinase in the hemorrhoidal acute disease”.

Secondary indentifying numbers:

IG/SKO/HM/0701

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Heber Biotec S.A.

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 :

02/07/2007

Reference number:

1283/05.006.07.B

Principal investigator

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

First name:

Liván, Hilario

Last name:

Quintero Tabío, Martínez Noda

Medical Specialty :

Specialist 2nd degree in Coloproctology

Affiliation:

"Camilo Cienfuegos" Clinical-Surgical Hospital, Sancti Spíritus. Medical – Surgical Research Center, Havana (CIMEQ)

Postal address:

216 street and 11-B, Siboney, Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-78581000

Email address:

email@not.entered [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:

Pinar del Rio, “Abel Santamaria” General Hospital, Dr. Lazaro Ramirez Arteaga.

Havana, “Calixto Garcia” General Hospital, Dr. Idania Rojas Bartolome.

Cienfuegos, “Gustavo Aldereguia” Universitary Hospital, Dr. Juan E. Dominguez Suarez.

Villa Clara, “Arnaldo Milian” Universitary Hospital, Dr. Roberto Fernandez Gonzalez.

Granma, “Celia Sanchez” Clinical-Surgical Hospital, Dr. Jose R. Causa Garcia.

Holguin, “Vladimir I. Lenin” Clinical-Surgical Hospital, Dr. Amalia Pupo Zunniga.

Santiago de Cuba, “Juan B. Zayas” General Hospital, Dr. Georgina Castellanos Sierra.

Guantanamo, “Agostinho Neto” General Hospital, Dr. Elvira Poch Mulgado.

Research ethics committees:

“Abel Santamaria” General Hospital, Pinar del Rio, June 14, 2007.

Medical – Surgical Research Center, Havana. March 28, 2007

“Calixto Garcia” General Hospital, Havana, November 29, 2007.

“Gustavo Aldereguia” Universitary Hospital, Cienfuegos, April 16, 2007.

“Arnaldo Milian” Universitary Hospital, Santa Clara, Villa Clara, April 16, 2007.

''Camilo Cienfuegos'' Clinical-Surgical Hospital, Sancti Spíritus, March 27, 2007.

“Celia Sánchez” Clinical-Surgical Hospital, Manzanillo, Granma, April 25, 2007.

“Vladimir I. Lenin” Clinical-Surgical Hospital, Holguín, May 5, 2007.

“Juan B. Zayas” General Hospital, Santiago de Cuba, April 17, 2007.

“Agostinho Neto” General Hospital, Guantánamo, March 28, 2007.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

02/10/2007

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:

Hemorrhoidal crisis.

Health condition(s) code:

Hemorrhoids

Rectal Diseases

Intestinal Diseases

Gastrointestinal Diseases

Digestive System Diseases

Vascular Diseases

Intervention(s):

The products under study will be administered, according to the random distribution, by rectal route in the form of suppositories [A) Recombinante Streptokinase suppository 200 000 UI, B) Recombinante Streptokinase suppository 100 000 UI, A) Sodium salicylate suppository, Placebo suppository]: 1 suppository every 6 hours for 24 hours.

Intervention code:

Streptokinase

Salicylates

Suppositories

Administration, Rectal

Placebos

Intervention keyword:

suppository of Recombinant Streptokinase

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):

Healing at the 5th day after starting treatment, according to the following criteria: all patients with Total Response in the evaluation at 5 days, given by the complete disappearance of pain and edema, and the reduction of more than 90% of the initial size of the lesion with neither absence of relapse nor need of thrombectomy.

Key secondary outcomes:

Clinical response at 24 and 72 hours after starting treatment. Edema, the presence or not will assess through direct physical examination (inspection) of the region. Pain, measured by a scale of pain faces (validated) Size of the lesion; it is an indirect measure and more objective of the development of edema; for this the patient will be placed in prone position with exposure of the anal part and will be measured (ruler in millimeters) in centimeters (at the inclusion, 24 horas, and at 3 and 5 days after starting treatment) the largest horizontal and vertical diameters of the lesion. Need to apply surgery. Relapse (at the 5th day and in the consultation for a follow up at 20 days).

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:

Diagnosis of haemorrhoidal acute illness. Age equal or superior to 18 years. Voluntary patient signing the informed consent.

Exclusion criteria:

History of intracranial hemorrhage. History of cerebrovascular disease, intracranial surgery or head trauma <3 months. Digestive or urinary bleeding <21 days. Recent surgery <14 days. Recent serious trauma <4 weeks. Puncture of major vessels no compressible in the last 7 days. Thrombin time > 20 seconds or a coagulation time > 10 seconds. Treatment with anticoagulant pharmaceuticals. Active internal bleeding (<3 weeks) or other conditions where there is significant risk of bleeding or would be difficult to manage because of its location. Hemorrhoidal disease caused by portal hypertension. Hemorrhoidal disease associated with abscess, fistula or cancer. Hemorrhoidal disease with septic complications or active hemorrhage. Administration of Streptokinase in the preceding 6 months. History of allergy to Streptokinase, Thiomersal or Salicylates (including aspirin), or any ingredient of the formulations under study. Pregnancy or lactation. Obvious mental incapacity to give consent, and act accordingly to 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:

Placebo

Study design:

Parallel

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:

Hernández-Bernal

Specialty:

2nd Degree Specialist in Hygiene and Epidemiology

Affiliation:

Center for Genetic Engineering and Biotechnology.

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacan, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887

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:

Hernández-Bernal

Specialty:

2nd Degree Specialist in Hygiene and Epidemiology

Affiliation:

Center for Genetic Engineering and Biotechnology.

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887

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:

RPCEC00000018

Date of Registration in Primary Registry:

2010-12-20

Record Verification Date:

2017/01/20

Next update date:

2018/01/20

Link to the spanish version:

Click here [3]