Desloratadine in Patients With Ulcerative Colitis

NCT07333716 | Recruiting Phase 2 DMC

• 1 other identifier: 12/2025 TRop1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate safety and therapeutic efficacy of antihistamine (desloratadine) on inflammation and disease activity when administered as adjuvant therapies with the traditional therapy 5-aminosalisylic acid (mesalamine) in patients with mild to moderate ulcerative colitis.

Conditions

Ulcerative Colitis (UC); Ulcerative Colitis

Keywords

Ulcerative Colitis; Desloratadine

Outcome Measures

Primary Outcomes (1)

• Change in disease activity and severity

  Change in disease activity and severity through Partial Mayo Scoring Index (PMSI) and Truelove and Witt's classification

  over a 3 month follow -up period

Secondary Outcomes (1)

• Change in serum biomarkers

  Change from baseline in serum biomarker over 3 months

Study Arms (2)

Group I (Control group)

PLACEBO COMPARATOR

which will receive mesalamine (standard treatment ) 1000 mg three times daily for 3 months and serve as the control group

Drug: mesalamine

Group II (Desloratadine group)

ACTIVE COMPARATOR

which will receive mesalamine (standard treatment )1000 mg three times daily plus desloratadine 5 mg once daily for 3 months

Drug: Desloratadine

Interventions

mesalamine DRUG

mesalamine 1000 mg three times daily for 3 months

Group I (Control group)

Desloratadine DRUG

mesalamine 1000 mg three times daily plus desloratadine 5 mg once daily for 3 months.

Group II (Desloratadine group)

Eligibility Criteria

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

You may qualify if:

• Both male and female sex.
• patients with age ranged from 18 to 65.
• patients with active mild and moderate ulcerative colitis according to American College of Gastroenterology (ACG) Clinical Guideline.
• Patients treated with 5-aminosalisylic acid (mesalamine).

You may not qualify if:

• Patients with severe UC
• Significant liver or kidney function abnormalities
• Pregnant or lactating females
• Treatment with systemic or rectal steroids
• Treatment with immunosuppressant or biological therapies
• Known allergy to desloratadine or any ingredient in the formulation
• Patients with other inflammatory diseases
• Patients with history of colon cancer
• Patients with complete or partial colectomy

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Menofia university Hospitals

Shibīn al Kawm, Menofia, 32511, Egypt

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

desloratadine; Mesalamine

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

Study Officials

• Romisaa R Abd Alnapy

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romisaa R Abd Alnapy

CONTACT

+201288667650; PG_182624@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacy resident

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 12, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)