- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05561062
Atorvastatin in Patients With Ulcerative Colitis
April 9, 2024 updated by: Mostafa Bahaa, Tanta University
Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood.
Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering property.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mostafa Bahaa, PhD
- Phone Number: 0201025538337
- Email: mbahaa@horus.edu.eg
Study Locations
-
-
-
Mansoura, Egypt, 35511
- Recruiting
- Faculty of Medicine, Mansoura University
-
Contact:
- Mostafa M Bahaa, PhD
- Phone Number: 0201025538337
- Email: mbahaa@horus.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years
- Both male and female will be included
- Negative pregnancy test and effective contraception
Exclusion Criteria:
- Breastfeeding
- Significant liver and kidney function abnormalities
- Colorectal cancer patients
- Patients with severe UC
- Patients taking rectal or systemic steroids
- Patients taking immunosuppressives or biological therapies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
This group will take 1 g mesalamine three times daily
|
|
Active Comparator: Atorvastatin group
This group will take 1 g mesalamine three times daily and atorvastatin 80 mg once daily
|
Atorvastatin is one of the most effective drugs used to reduce intracellular cholesterol synthesis.
it exerts numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of its basic lipid-lowering properties
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in health related quality of life
Time Frame: 6 months
|
HRQL questionnaire will be assessed according to a short-form (SF-36) questionnaire.
The SF-36 is an indicator of overall health status and contains 10 items.
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section.
Scores range from 0 - 100.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in the level of inflammatory biomarkers
Time Frame: 6 months
|
changes in the level of inflammatory biomarkers such as IL-6, fecal myeloperoxidase
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
June 20, 2027
Study Registration Dates
First Submitted
September 27, 2022
First Submitted That Met QC Criteria
September 27, 2022
First Posted (Actual)
September 30, 2022
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Colitis
- Colitis, Ulcerative
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- 9/22021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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