THERESA-4 Study

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000122
• Date of registration: 25/10/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: THERESA-4 Study
• Scientific title: Recombinant streptokinase and Anusol-HC suppositories in the treatment of hemorrhoids and thrombosis fluxion.
• Date of first enrolment: 15/11/2011
• Target sample size: 510
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000122-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Open. Placebo: Active Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Francisco Hernández Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Francisco Hernández Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

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.

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

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).

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.

Secondary Outcome(s)

- 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.

Secondary ID(s)

IG/SKO/HM/1104

Source(s) of Monetary Support

Center for Genetic Engineering and Biotechnology (CIGB).

Secondary Sponsor(s)

Not aplicable.