THERESA-4 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:

Recombinant streptokinase and Anusol-HC suppositories in the treatment of hemorrhoids and thrombosis fluxion.

Secondary indentifying numbers:

IG/SKO/HM/1104

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB).

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB).

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)

Reference number:

01-248-11-B (Procedure code), October 04, 2011

Principal investigator

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

First name:

Georgina Castellanos Sierra, MD. 2nd grade Specialist in Coloproctology.

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, General Hospital "Abel Santamaría", Lázaro Ramírez Arteaga MD, 1st Degree Specialist in General Surgery. Cienfuegos, Universitary General Hospital "Gustavo Lima Aldereguía", Juan Emilio Suárez Domínguez MD, 2nd Degree Specialist in Coloproctology. Villa Clara, University Hospital "Arnaldo Milián Castro", Roberto Fernández González MD, 2nd Degree Specialist in Coloproctology. Villa Clara, Hospital "Mártires del 9 de abril", Sergio Sans Brown MD, 1st Degree Specialist in Coloproctology. Sancti Spíritus, General Hospital "Camilo Cienfuegos", Ramón Morales Germán MD, 1st Degree Specialist in Coloproctology. Ciego de Ávila, Provincial Hospital "Antonio Luaces", Eriberto Beltrán Hernández MD, 1st Degree Specialist in Coloproctology. Las Tunas, Provincial General Hospital "Dr. Ernesto Che Guevara", Osmany Martínez Serrano MD, 1st Degree Specialist in Coloproctology. Granma, Clinical-Surgical Hospital "Celia Sánchez", José Roberto Causa García MD, 1st Degree Specialist in Coloproctology. Granma, University Hospital "Carlos Manuel de Céspedes", Braulio Fernández Cambón MD, 1st Degree Specialist in General Surgery. Holguin, General Hospital Univesitario "Vladimir Ilich Lenin", Amalia Margarita Pupo Zuñiga MD, 2nd Degree Specialist in Coloproctology. Guantánamo, General Hospital "Agostinho Neto", Elvira Poch Mulgan MD, 2nd Degree Specialist in Coloproctology.

Research ethics committees:

General Hospital “Dr. Juan Bruno Zayas Alfonso”, July 13, 2011. General Hospital "Abel Santamaría", October 06, 2011. Universitary General Hospital "Gustavo Lima Aldereguía", September 09, 2011. University Hospital "Arnaldo Milián Castro", July 18, 2011. Hospital "Mártires del 9 de abril", August 04, 2011. General Hospital "Camilo Cienfuegos", July 15, 2011. Provincial Hospital "Antonio Luaces", September 27, 2011. Provincial General Hospital "Dr. Ernesto Che Guevara", July 14, 2011. Clinical-Surgical Hospital "Celia Sánchez", July 12, 2011. University Hospital "Carlos Manuel de Céspedes", July 14, 2011. General Hospital Univesitario "Vladimir Ilich Lenin", July 12, 2011. General Hospital "Agostinho Neto", July 14, 2011.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

15/11/2011

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:

Fluxion and thrombosed hemorrhoid.

Intervention(s):

Group I (recombinant streptokinase suppositories [Proctokinasa - 200 000 IU, Heber Biotec SA, Havana], Scheme A): In the first 24 hours, administered rectally 1 suppository every 8 hours (3 units), followed by 1 suppository every 12 hours (5 suppositories) to complete 8 units in total. Group II (recombinant streptokinase suppositories [Proctokinasa - 200 000 IU, Heber Biotec SA, Havana], Scheme B) administered rectally 1 suppository every 8 hours to complete 6 units (48 hours). Group III (Anusol-HC Suppository [Hydrocortisone Acetate], Salix Pharmaceuticals, USA): 1 suppository administered every 8 hours to a maximum of 24 units (8 days).

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 after initiation of treatment (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: 3, 5, and 10 days post-treatment. - Cessation of pain and anal bleeding (Yes, No). Measuring time: 3, 5, and 10 days post-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: 72 hours, the 5th and 10th days post-treatment. - Need for thrombectomy (Yes, No). Measuring time: during the implementation period of the trial. - 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: 72 hours, the 5th and 10th days post-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:

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 between 18 and 75 years inclusive. 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) Background of intracranial hemorrhage. 2) History of cerebrovascular disease, intracranial surgery or head trauma <3 months. 3) Gastrointestinal bleeding or urinary tract <21 ??days. 4) Recent surgery <14 days. 5) Recent serious trauma <4 weeks. 6) Puncture of major vessels is not understandable in the last 7 days. 7) Treatment with anticoagulants. 8) Active internal bleeding (<3 weeks) or other conditions where there is risk of major bleeding, or would be difficult to handle because of their location. 9) Hemorrhoidal disease caused by portal hypertension. 10) Hemorrhoidal disease with septic complications, or associated with abscess, fistula or cancer. 11) Acute diarrheal disease in the last 12 hours. 12) Treatment with streptokinase in the preceding 6 months. 13) History of allergy to streptokinase, thiomersal, salicylates (including aspirin), corticosteroids, or any ingredient of the formulations under study. 14) Pregnancy or lactation at the time of inclusion in the study. 15) 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:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

510

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:

Dr. Francisco

Last Name:

Hernández Bernal

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

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

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-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:

Hernández Bernal

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

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

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

53-7)-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:

RPCEC00000122

Date of Registration in Primary Registry:

2011-10-25

Record Verification Date:

2011-10-24 20:00

Link to the spanish version:

Click here [3]