Role of Roflumilast in Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: amino salicylic acidDrug: Roflumilast 500 MCG Oral Tablet [DALIRESP]
- Registration Number
- NCT05684484
- Lead Sponsor
- Tanta University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Patients referred to endoscopy units in Tanta University hospitals during the period of the study.
Patient with mild to moderate UC diagnosed as:
- 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.
- Endoscopy : are necessary to establish the chronicity of inflammation and to exclude other causes of colitis.
- 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 )
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mesalamine group amino salicylic acid Placebo Group (n=26): Patients will receive mesalamine 500 mg once daily forulcerative colitis for 3 months. Roflumilast group Roflumilast 500 MCG Oral Tablet [DALIRESP] Patients will receive mesalamine and Roflumilast (500 mcg ) orally once daily for 3 months
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
faculty of pharmacy Tanta university
🇪🇬Tanta, Egypt