Rupatadine in Patients With Ulcerative Colitis

NCT07064707 | Recruiting Phase 2

• 1 other identifier: 5555
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Ulcerative colitis (UC) is a chronic inflammatory condition that primarily targets the large intestine. Although substantial progress has been made in treatment modalities-especially with the development of immunomodulatory drugs and biologic therapies-managing UC continues to present significant challenges. At present, there is no definitive cure, and current treatment strategies are largely focused on controlling inflammation, relieving symptoms, and halting disease progression

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• change in partial mayo score

  The Partial Mayo Score (PMS) index will be utilized to ascertain the degree of disease severity. One non-invasive clinical measure for determining the severity of UC is the PMS. The composite score is derived from three subcategories: stool frequency, rectal bleeding, and physician's general assessment. The total score falls between 0 and 9

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

control group (Mesalamine group) who will receive 1 g mesalamine three times daily for 3 months.

Drug: Mesalamine

Rupatadine

ACTIVE COMPARATOR

(Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once daily for 3 months.

Drug: Mesalamine; Drug: Rupatadine

Interventions

Mesalamine DRUG

Mesalamine or 5-amino salicylic acid (5-ASA), plays a crucial role in the treatment of ulcerative colitis (UC). It is the first-line therapy for mild to moderate cases of UC and is considered a cornerstone in its management.

Control group; Rupatadine

Rupatadine DRUG

Rupatadine, a dual histamine H1 receptor and platelet-activating factor (PAF) receptor antagonist, has shown promising anti-inflammatory effects beyond its conventional use in allergic conditions

Rupatadine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Both male and female will be included
• Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.

You may not qualify if:

• Breast feeding or pregnancy.
• Colorectal cancer patients.
• Patients with severe UC.
• Patients taking rectal or systemic steroids.
• Patients taking immunosuppressives or biological therapies.
• Addiction to alcohol and / or drugs.
• Known allergy to the studied medications.

Sponsors & Collaborators

• Alexandria University: lead
• Prof. Dr. Ahmed Ibrahim Mohammed El Mallah, faculty of pharmacy, Alexandria University.: collaborator
• Assoc. Prof. Dr. Noha Alaa Eldin Hassan Hamdy, Faculty of pharmacy, Alexandria University.: collaborator
• Assoc. Prof. Dr. Ibrahim Fathi Amer, Faculty of Medecine, Kafr Elsheikh University.: collaborator

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine; rupatadine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Central Study Contacts

Reham Elshafiey, PhD

CONTACT

01025465180; rehamelshafiey@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate lecturer of clinical pharmacy

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 15, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): October 21, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

EG (1)