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Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

Primary Purpose

Inflammatory Bowel Diseases

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Atorvastatin 80mg
Mesalamine
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Both males and females 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

Sites / Locations

  • Faculty of Medicine, Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control Group

Atorvastatin group

Arm Description

This group will take mesalamine 1 g three times daily

This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.

Outcomes

Primary Outcome Measures

Improvement in health related quality of life
HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms

Secondary Outcome Measures

changes in serum and fecal inflammatory biomarkers
The secondary endpoint is estimated by changes in serum IL-18, and fecal calprotectin.

Full Information

First Posted
October 1, 2022
Last Updated
March 19, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05567068
Brief Title
Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis
Official Title
Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 1, 2026 (Anticipated)
Study Completion Date
September 20, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
double-blinded.
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
This group will take mesalamine 1 g three times daily
Arm Title
Atorvastatin group
Arm Type
Active Comparator
Arm Description
This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80mg
Intervention Description
Atrovastatin 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
Intervention Type
Drug
Intervention Name(s)
Mesalamine
Intervention Description
Mesalamine
Primary Outcome Measure Information:
Title
Improvement in health related quality of life
Description
HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms
Time Frame
6 months
Secondary Outcome Measure Information:
Title
changes in serum and fecal inflammatory biomarkers
Description
The secondary endpoint is estimated by changes in serum IL-18, and fecal calprotectin.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Both males and females 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
Facility Information:
Facility Name
Faculty of Medicine, Mansoura University
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa M Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg

12. IPD Sharing Statement

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Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

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