Ulcerative Colitis
Conditions
Interventions
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
Epidermal Growth Factor
Mesalamine
Administration, Oral
Placebos
CIGB-400,
recombinant human Epidermal Growth Factor
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), Havana City.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response: It will be evaluated at 2, 6 and 14 weeks of having started the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactHugo Nodarse Cuni
Center for Genetic Engineering and Biothecnology (CIGB), in Havana.
Outcome results
None listed