THERESA-5 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.

Acronym of Public Title:

THERESA-5

Scientific title:

Proctokinasa® in the treatment of acute hemorrhoid. National Pharmacovigilance.

Secondary indentifying numbers:

IG/SKO/HM/1505

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., Cuba.

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Georgina

Last name:

Castellanos Sierra

Medical Specialty :

MD. 2nd grade Specialist in Coloproctology

Affiliation:

"Juan B. Zayas" hospital

Postal address:

Carretera del Caney s/n esquina 23, Reparto Pastorita

City:

Santiago de Cuba

País:

Cuba

Zip Code:

Telephone:

+53-22641903

+53-22642358

Email address:

georgina@hospclin.scu.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:

Pinar del Rio, General Hospital "Abel Santamaria", Lazaro Ramirez Arteaga MD, 1st Degree Specialist in General Surgery.

Havana, "Hermanos Ameijeiras" Clinical-Surgical Hospital, Maria E. González Solares MD, 2nd Degree Specialist in Coloproctology.

Havana, "Calixto Garcia" Universitary Hospital, Idania T. Rojas Bartolome MD, Specialist 1st grade in Coloproctology.

Mayabeque, "Leopoldito Martínez" General Hospital, Osvaldo Barrios Viera MD, 2nd Degree Specialist in General Surgery.

Cienfuegos, “Dr. Gustavo Aldereguia Lima” Universitary Hospital, Jose A. Filiu Rosa MD, Specialist 1st grade in Coloproctology.

Villa Clara, “Arnaldo Milian Castro” Universitary Hospital, Roberto Fernandez Gonzalez MD, 2nd Degree Specialist in Coloproctology.

Villa Clara, “Martires del 9 de Abril” General Hospital, Rene Vazquez Estevez MD, 1st Degree Specialist in General Surgery.

Villa Clara, Placetas General Hospital, Yusmara Castiñeira Portal MD, 1st Degree Specialist in General Surgery.

Sancti Spiritus, “Camilo Cienfuegos” General Hospital, Ramon Morales Alemán MD, Specialist 1st grade in Coloproctology.

Ciego de Avila, “Dr. Antonio Luaces" Provincial Hospital, Joaquin Agramonte Hernandez MD, Specialist 1st grade in Coloproctology.

Las Tunas, "Dr. Ernesto Che Guevara" General Hospital, Osmany Martinez Serrano MD, Specialist 1st grade in Coloproctology.

Granma, “Carlos Manuel de Cespedes” Universitary Hospital, Carmen M. Pérez Suárez MD, 2nd Degree Specialist in General Surgery.

Granma, "Celia Sanchez" Provincial Clinical - Surgical Hospital, Jose R. Causa García MD, Specialist 1st grade in Coloproctology.

Holguin, “Vladimir Ilich Lenin” Universitary Hospital, Amalia M. Pupo Zuñiga MD, 2nd Degree Specialist in Coloproctology.

Santiago de Cuba, “Victoria de Giron” Community Polyclinic, Reynaldo Montalvan Medina MD, Specialist 1st grade in Coloproctology.

Guantanamo, “Dr. Agostinho Neto” General Hospital, Kenia R. Alvarez Lambert MD, Specialist 1st grade in Coloproctology.

Research ethics committees:

“Dr. Juan Bruno Zayas Alfonso” General Hospital, February 9, 2015.

General Hospital "Abel Santamaraa", March 17, 2015.

"Hermanos Ameijeiras" Clinical-Surgical Hospital, February 27, 2015.

"Calixto Garcia" Universitary Hospital, March 3, 2015.

"Leopoldito Martinez" General Hospital, March 16, 2015.

“Dr. Gustavo Aldereguia Lima” Universitary Hospital, March 19, 2015.

“Arnaldo Milian Castro” Universitary Hospital, February 27, 2015.

“Martires del 9 de Abril” General Hospital, February 10, 2015.

Placetas General Hospital, March 12, 2015.

“Camilo Cienfuegos” General Hospital, February 27, 2015.

“Dr. Antonio Luaces" Provincial Hospital, February 13, 2015.

"Dr. Ernesto Che Guevara" General Hospital, February 18, 2015.

“Carlos Manuel de Cespedes” Universitary Hospital, February 13, 2015.

"Celia Sanchez" Provincial Clinical - Surgical Hospital, February 16, 2015.

“Vladimir Ilich Lenin” Universitary Hospital, February 19, 2015.

“Victoria de Giron” Community Polyclinic, February 9, 2015.

“Dr. Agostinho Neto” General Hospital, February 12, 2015.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

05/03/2015

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 hemorrhoids

Intervention(s):

Study group: Treatment with Recombinant streptokinase suppositories (Proctokinasa®; SK 200 000 IU). Be given 4 suppositories (1 suppository every 8 hours). If after 48 hours the patient has not reached 50% reduction of the initial hemorrhoidal lesion may indicate treatment with 2-4 additional units Proctokinasa® (also with a frequency of administration every 8 hours).

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):

Clinical response (complete response [no anal pain, rectal bleeding and no reduction of 70% or more of the initial size of the lesion hemorrhoidal] Partial Response [presence of pain and / or rectal bleeding but with reduced level of intensity, and hemorrhoidal lesion reduction of 50-69%]; no Response [no reduction in pain intensity and / or rectal bleeding, and reduction of less than 50% of the lesion hemorrhoidal]) . Measuring time: 48 hours, 4th, 6th and 10th days after the start of treatment. Cessation of pain and anal bleeding (Yes, No). Measuring time: 48 hours, 4th, 6th and 10th days after the start of treatment.

Key secondary outcomes:

- Termination of the other clinical manifestations (edema, pruritus, sensation of a mass, tenesmus, constipation, anal burning and diarrhea, among others) (Yes, No). Measuring Time: 48 hours, 4th, 6th and 10th days after the start of treatment. - Need for thrombectomy (Yes, No). Measuring time: 48 hours, 4th, 6th and 10th days after the start of treatment. . - Adverse events (number of events, type, frequency: Yes, No, Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related adverse event; Duration: hours, days Causation: remote, possible, likely, very likely; Result: Completely resolved, Resolved with sequelae, conditions improved, still present and unchanged conditions, worsening, Death, treatment indicated: type and dosage of medication, treatment time). Measurement time: 48 hours, 4th, 6th and 10th days after the start of treatment. - Presence of anti-streptokinase antibodies (Yes, No). Measuring time: 10 days after starting the treatment.

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) Compliance with the diagnostic criteria (fluxion and / or thrombosed hemorrhoid anal pain characterized by sudden onset, with tumors of variable size and appearance and can be red-violet color, usually associated with significant swelling). 2) Age ≥ 18 years. 3) Anal pain (of any degree of intensity) and / or bleeding at the time of inclusion in the study. 4) Voluntariness of the patient by signing the informed consent.

Exclusion criteria:

1. Active internal bleeding (<3 weeks) or other conditions where there is risk of major bleeding, or would be unwieldy because of its location. 2. acute diarrheal disease in the past 12 hours. 3. History of allergy to streptokinase, thiomersal, salicylates (including aspirin), or any ingredients of the formulations under study. 4. Pregnancy or lactation at the time of inclusion in the study. 5. Mental incapacity to give consent clearly 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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

1500

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 Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+537-2085887, 2087465

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 Biotechnology (CIGB).

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

10600

Telephone:

+537 2085887, 2087465

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:

RPCEC00000191

Date of Registration in Primary Registry:

08/04/2015

Record Verification Date:

2015/04/08

Next update date:

2016/04/08

Link to the spanish version:

Click here [3]