Clinical trial NCT05684484: Role of Roflumilast in Ulcerative Colitis
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ulcerative Colitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility criteria: 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 )

Primary outcomes:
measure: clinical improvement in ulcerative colitis severity
timeFrame: 3 months
Secondary outcomes:
measure: changes in serum levels of the measured biochemical parameters
timeFrame: 7 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: faculty of pharmacy Tanta university
Study officials:
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