THERESA-2 Study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000018
• Date of registration: 20/12/2010
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB)
• Public title: THERESA-2 Study
• Scientific title: “Efficacy and safety of the suppository of Recombinant Streptokinase in the hemorrhoidal acute disease”.
• Date of first enrolment: 02/10/2007
• Target sample size: 80
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000018-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo 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: Diagnosis of haemorrhoidal acute illness. Age equal or superior to 18 years. 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. Thrombin time > 20 seconds or a coagulation time > 10 seconds. 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. Hemorrhoidal disease caused by portal hypertension. Hemorrhoidal disease associated with abscess, fistula or cancer. Hemorrhoidal disease with septic complications or active hemorrhage. Administration of Streptokinase in the preceding 6 months. History of allergy to Streptokinase, Thiomersal or Salicylates (including aspirin), 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: N/A (No limit)
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, B) Recombinante Streptokinase suppository 100 000 UI, A) Sodium salicylate suppository, Placebo suppository]: 1 suppository every 6 hours for 24 hours.

Primary Outcome(s)

Healing at the 5th day after starting treatment, according to the following criteria: all patients with Total Response in the evaluation at 5 days, given by the complete disappearance of pain and edema, and the reduction of more than 90% of the initial size of the lesion with neither absence of relapse nor need of thrombectomy.

Secondary Outcome(s)

Clinical response at 24 and 72 hours after starting treatment. Edema, the presence or not will assess through direct physical examination (inspection) of the region. Pain, measured by a scale of pain faces (validated) 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, 24 horas, and at 3 and 5 days after starting treatment) the largest horizontal and vertical diameters of the lesion. Need to apply surgery. Relapse (at the 5th day and in the consultation for a follow up at 20 days).

Secondary ID(s)

IG/SKO/HM/0701

Source(s) of Monetary Support

Heber Biotec S.A.

Secondary Sponsor(s)

Ministry of Public Health, CUBA