FASECU I

Phase 2

Recruiting

• Conditions: Colitis; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Gastroenteritis; lcerative Colitis; Colitis, Ulcerative; Gastrointestinal Diseases; Digestive System Diseases

• Registration Number: RPCEC00000065
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana City.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified