THERESA-3 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:

“Treatment of the hemorrhoidal crisis with recombinant Streptokinase suppositories”.

Secondary indentifying numbers:

IG/SKO/HM/0903

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

HeberBiotec 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 :

05/07/2009

Reference number:

769/05.010.09.B

Principal investigator

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

First name:

''Camilo Cienfuegos'' Clinical-Surgical Hospital, Dr. Liván Quintero Tabío “Hermanos Ameijeiras'' Clinical-Surgical Hospital, Dra. María Elena González Solares

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

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 Río., “Abel Santamaría” General Hospital, Dr. Lázaro Ramírez Arteaga Havana City., “Joaquín Albarrán” Clinical-Surgical Hospital, Dra. Mercedes Bandera Ramírez Havana City., “Luis Díaz Soto” Military Hospital, Dr. Miguel Fonte Sosa Havana City., “Calixto García” General Hospital, Dra. Idania Rojas Bartolomé Cienfuegos., “Gustavo Aldereguía” Universitary Hospital, Dr. Osvaldo Pomares Calderón Villa Clara., “Arnaldo Milián” Universitary Hospital, Dr. Roberto Fernández Las Tunas., “Ernesto Ché Guevara” General Hospital, Dr. Osmany Martínez Serrano Bayazo-Granma., “Carlos M. de Céspedes” Universitary Hospital, Dr. Gerardo Prieto Fajardo Manzanillo-Granma., “Celia Sánchez” Clinical-Surgical Hospital, Dr. Miguel Fernández Gautier Holguín., “Vladimir I. Lenin” Clinical-Surgical Hospital, Dra. Amalia Pupo Santiago de Cuba., “Juan B. Zayas” General Hospital, Dra. Georgina Castellanos Sierra Guantánamo., “Agostinho Neto” General Hospital, Dra. Elvira Poch Mulgado

Research ethics committees:

“Abel Santamaría” General Hospital, Pinar del Río, April 10th, 2009. ''Hermanos Ameijerias'' Clinical-Surgical Hospital, Havana City, June 1th, 2009. “Joaquín Albarrán” Clinical-Surgical Hospital, Havana City, September 7th, 2009. “Luis Díaz Soto” Military Hospital, Havana City, May 6th, 2009. “Calixto García” General Hospital, Havana City, May 6th, 2009. “Gustavo Aldereguía” Universitary Hospital, Cienfuegos, July 15th, 2009. “Arnaldo Milián” Universitary Hospital, Santa Clara, Villa Clara, May 18th, 2009. ''Camilo Cienfuegos'' Clinical-Surgical Hospital, Sancti Spíritus, April 20th, 2009. “Ernesto Ché Guevara” General Hospital, Las Tunas, June 10th, 2009. “Carlos M. de Céspedes” Universitary Hospital, Bayamo, Granma, April 22th, 2009. “Celia Sánchez” Clinical-Surgical Hospital, Manzanillo, Granma, April 10th, 2009. “Vladimir I. Lenin” Clinical-Surgical Hospital, Holguín, May 26th, 2009. “Juan B. Zayas” General Hospital, Santiago de Cuba, April 7th, 2009. “Agostinho Neto” General Hospital, Guantánamo, April 10th, 2009.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

29/11/2009

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.

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 (CIGB, Havana): 1 suppository every 6 hours for 48 hours; B) Suppository Preparation H: 1 suppository every 6 hours for a maximum of 5 days (suspend earlier if: the clinical manifestations disappear [patient evaluated with total response], if the physician decides to perform thrombectomy or other surgical procedure, and if a serious adverse event occurs.

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 at the 5th day after starting treatment, according to the following criteria: TOTAL Response: Complete disappearance of pain and edema (or mild intensity), and reduction of 70% or more of the initial size of the hemorrhoidal lesion. PARTIAL Response: Presence of pain and edema but with reduced intensity, and 50 - 69% reduction of the size of the lesion. No RESPONSE: No reduction in pain intensity and / or edema, and reduction of less than 50% of the hemorrhoidal lesion.

Key secondary outcomes:

Clinical response at 72 hours and at the 10th day after starting treatment. Edema, the presence or not will assess through direct physical examination (inspection) of the region. Pain, measured using the same intensity criteria used to assess the adverse events (mild, moderate or severe). 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, and at 5 and 10 days after starting treatment) the largest horizontal and vertical diameters of the lesion. Need for surgery (yes/no) at the 10th day after starting 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:

75 years

Inclusion criteria:

Fulfillment of the diagnostic criteria (there will be considered eligible all patients of both sexes with a clinical diagnosis of acute hemorrhoids characterized by anal pain of sudden onset, with tumors of variable size and appearance, and may be colored red-violet, usually associated with a significant edema). Aged between 18 and 75 years, inclusive. 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. 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. History of severe arterial hypertension or ventricular tachycardia. History of hereditary coagulopathy (factor VIII deficiency [classic hemophilia] and IX [Christmas disease] of clotting). Decompensated chronic disease (diabetes mellitus, heart insufficiency, and hyperthyroidism). Peripheral or mesenteric vascular thrombosis. Difficulty in secondary urination due to prostatic hyperplasia. Hemorrhoidal disease caused by portal hypertension. Hemorrhoidal disease associated with abscess, fistula or cancer. Hemorrhoidal disease with septic complications or active hemorrhage. Acute diarrheal disease in the last 12 hours. Administration of Streptokinase in the preceding 6 months. History of allergy to Streptokinase, Thiomersal or Salicylates (including aspirin), Phenylephrine, 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:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

220

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

Affiliation:

Center for Genetic Engineering and Biotechnology.

Postal Address:

Ave. 31 e/ 158 y 190

City:

Cubanacán, Playa, Havana City

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

Affiliation:

Center for Genetic Engineering and Biotechnology.

Postal Address:

Ave. 31 e/ 158 y 190

City:

Cubanacán, Playa, Havana City.

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:

RPCEC00000093

Date of Registration in Primary Registry:

2009-12-11

Record Verification Date:

2009-12-02 19:00

Link to the spanish version:

Click here [3]