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NCT05684484CompletedPhase 4

Role of Roflumilast in Ulcerative Colitis

Clinical Study to Evaluate the Possible Efficacy and Safety of Roflumilast in Patients With Ulcerative Colitis.

Source: ClinicalTrials.gov · Last updated 28 Jan 2025

Brief summary (registry, in English)

This study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease .

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
52 (actual)
First submitted
26 Dec 2022
Start date
1 Feb 2023
Primary completion date
15 Apr 2024
Lead sponsor
Tanta University
NCT number
NCT05684484

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 52
  • From 1 Feb 2023 to the primary completion date, 15 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Other inflammatory bowel disease (crohn's disease) .
  • 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 .
  • Moderate to severe hepatic impairment (child pugh class B or C) .

Age

  • Patients \<15 and \>80 years

Other

  • Patients who didn't give consent to participate in the study
  • Depression , thoughts of suicide , anxiety and emotional instability .
  • Excessive weight loss .
  • Strong (CYP3A4) inducers : Barbiturates (phenobarbital) , Carbamazepine , Phenytoin , Rifampicin ( Risk , X interaction )
  • Loxapine ( Risk , X interaction )

Who the study is looking for

  • 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.

Age in the registry: 15 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Faculty of Pharmacy, Tanta University
Coordinator of this site? Confirm its status
TantaEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.