Ulcerative Colitis
Conditions
Brief summary
This study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease .
Detailed description
* Study design and study population This study will be randomized, controlled, parallel study. * It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups 1. Group 1 (n=26): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 3 months. 2. Group 2 (n=26): Patients will receive previous conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months * Patient will be selected from Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital. * A written informed consent will be obtained from all patients * This study will be approved by the Research Ethics Committee of Tanta University. * Any unexpected risks appeared during the course of research will be reported to the participants and ethical committee on time and documented through an adverse effects reporting form . * Randomization will be carried out based on days of hospital admission
Interventions
DRUGRoflumilast 500 MCG Oral Tablet [DALIRESP]
Roflumilast has been approved by U.S. Food and Drug Administration (FDA) for attenuating bronchial and dermatological disorders
DRUGamino salicylic acid
conventional treatment
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
It will be conducted on 52 patient having with mild to moderate degree ulcerative colitis disease divided into two groups 1. Placebo Group (n=26): Patients will receive conventional tratment only (amino salicylic acid) for 3 months. 2. Group 2 (n=26): Patients will receive conventional treatment and Roflumilast (500 mcg ) orally once daily for 3 months
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients referred to endoscopy units in Tanta University hospitals during the period of the study. Patient with mild to moderate UC diagnosed as: 1. Clinical signs: Patients with moderate clinical disease have frequent loose, bloody stools (\>4per day), mild anemia, and abdominal pain that is not severe. Patients have minimal signs of systemic toxicity, including a low-grade fever. Adequate nutrition is usually maintained, and weight loss. 2. Endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis.
Exclusion criteria
* Other inflammatory bowel disease (crohn's disease) . * Patients \<15 and \>80 years * Patients who didn't give consent to participate in the study * Patients with contraindications of colonoscopy e.g. suspected colonic perforation, acute peritonitis, pregnancy, severe bleeding tendency, shock, uncooperative patient and if toxic mega colon is suspected were excluded * History of allergic reaction to Roflumilast or any component of the formulation Like rash , hives ,itching and redness . * Depression , thoughts of suicide , anxiety and emotional instability . * Excessive weight loss . * Moderate to severe hepatic impairment (child pugh class B or C) . * Strong (CYP3A4) inducers : Barbiturates (phenobarbital) , Carbamazepine , Phenytoin , Rifampicin ( Risk , X interaction ) * Loxapine ( Risk , X interaction )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical improvement in ulcerative colitis severity | 3 months | To demonstrate the efficacy of Roflumilast and clinical improvement in (Mayo disease activity index) for assessment of ulcerative colitis severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in serum levels of the measured biochemical parameters | 7 months | demonstrate changes in serum levels of the measured biochemical parameters 1. Tumor necrosis factor-alpha (TNF-α) as pro inflammatory marker (ELISA). 2. Signal transducer and activator of transcription 3 (STAT3) as a potential marker for apoptosis ( ELISA) 3. Caspase-3 as a potential marker for apoptosis (ELISA). |
Countries
Egypt
Outcome results
None listed