FASECU I

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000065
• Date of registration: 16/10/2008
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana City.
• Public title: FASECU I
• Scientific title: Viscous solution of human recombinant Epidermal Growth Factor in the treatment of Ulcerative Colitis.
• Date of first enrolment: 16/02/2006
• Target sample size: 60
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000065-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: Hugo Nodarse Cuni
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

• Name: Hugo Nodarse Cuni
• Affiliation: Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Key inclusion & exclusion criteria

Inclusion criteria: 1. Informed written consent, signed by the patient 2. Age understood between 18 and 70 years, regardless of sex. 3. Patients with diagnosis of ulcerative colitis confined in the portion of the large intestine understood between the rectum and the splenic angle of the colon 4. Scale of evaluation based on the endoscopy with punctuation between 1 and 2. 5. Scale of evaluation based on the histology with punctuation between 1 and 2.6. Global evaluation scale: Index of severity of the disease: (DAI: Disease Activity Index Store) with punctuation between 3 and 10.
Exclusion criteria: 1. Patients with direct positive Examination of fecal dregs of Amebiasis. 2. Treatment with steroids in the last 30 days before the inclusion. 3. Treatment with immunosuppressants in the last three months before the inclusion. 4. Malignant Neoplasia (excepting the basal carcinoma of skin and the in situ carcinoma of neck of uterus already produced and with criterion of healing). 5. Arterial serious decompensated hypertension or cardiopathies. 6. Heart, hepatic or uncompensated renal failure. 7. Patients with known hypersensitivity to the mesalazine. 8. Severe psychiatric disorder or another limitation that prevents the patient from giving his consent. 9. Pregnancy, puerperium or lactation.

Age minimum: 18 years
Age maximum: 70 years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Brief description of the intervention (s): 1st stratum: Ulcerative Colitis, anal location, light to moderate: Group I: CIGB 400 (10 microg/mL) 75 mL in enemas and oral Mesalazine (1.2 g daily), Group II: Mesalacina enemas (1g in 100 ml), Group III: Placebo CIGB 400 (75 mL) and oral mesalazine (1.2 g daily). 2nd stratum: left ulcerative colitis, light to moderate: Group I: CIGB 400 (10 microg/mL) 75 mL in enemas and oral mesalazine (1.2 g daily), Group II: Mesalacina enemas (1g in 100 ml), Group III: Placebo CIGB 400 (75 ml) and oral mesalazine (1.2 g daily). The time of treatment is 14 days.

Primary Outcome(s)

Clinical response: It will be evaluated at 2, 6 and 14 weeks of having started the treatment.

Secondary Outcome(s)

Secondary Variables: Relapse-free time: It is the time in weeks since the date of the remission and the first relapsing of the disease. It is considered a relapse when the patient classifies in any different level of remission from the Index of severity of the disease: (DAI: Disease Activity Index Store): Number of relapse: This datum will be gathered until reaching 12 weeks of having the treatment of induction of the remission and it will be expressed in entire figures. Need of treatment with steroids and/or immunosuppressants: There will be evaluated if there was need or not of using steroids and/or immunosuppressants in case of having relapse at 12 weeks of having started the induction of the remission treatment.

Secondary ID(s)

IG/FCET/CU/0401

Source(s) of Monetary Support

Ministry of Public Health.