THERESA-3 Study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000093
• Date of registration: 11/12/2009
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB).
• Public title: THERESA-3 Study
• Scientific title: “Treatment of the hemorrhoidal crisis with recombinant Streptokinase suppositories”.
• Date of first enrolment: 29/11/2009
• Target sample size: 220
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000093-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Francisco Hernández-Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology.

• Name: Francisco Hernández-Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology.

Key inclusion & exclusion criteria

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.

Age minimum: 18 years
Age maximum: 75 years
Gender: Both

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.

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.

Secondary Outcome(s)

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

Secondary ID(s)

IG/SKO/HM/0903

Source(s) of Monetary Support

HeberBiotec S.A.

Secondary Sponsor(s)

Ministry of Public Health, CUBA