NCT00199238

Brief Summary

The objective of this study is to evaluate the efficacy and safety of rupatadine for the treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

September 12, 2005

Last Update Submit

February 2, 2022

Conditions

URTICARIA

Keywords

ANTIHISTAMINERUPATADINEWHEALFLAREDERMATOLOGY

Outcome Measures

Primary Outcomes (1)

  • Pruritus

    change in mean pruritus score (MPS) over the 4-week treatment period.

    4 weeks

Secondary Outcomes (3)

  • Wheals

    4 weeks

  • change in mean total symptoms score (MTSS) over the 4-week treatment period.

    4 weeks

  • overall impression

    4 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Once daily/ 28 days

Drug: Rupatadine Fumarate

rupatadine 5mg

EXPERIMENTAL

Once daily/ 28 days

Drug: Rupatadine Fumarate

rupatadine 10 mg

EXPERIMENTAL

Once daily/ 28 days

Drug: Rupatadine Fumarate

rupatadine 20 mg

EXPERIMENTAL

Once daily/ 28 days

Drug: Rupatadine Fumarate

Interventions

Rupatadine FumarateDRUG
Also known as: Placebo
Placeborupatadine 10 mgrupatadine 20 mgrupatadine 5mg

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman aged between 12 and 65
  • Documented history of active CIU (urticaria wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to Day 0
  • Results of standard laboratory biochemistry and haematology tests obtained at screening within acceptable limits as assessed by investigator
  • Patient who signed the informed consent form -

You may not qualify if:

  • CIU associated to some underlying disease (Hodgkin's disease/vasculitis/lupus erythematous/hepatitis)
  • Patient under any systemic or topical medication for CIU and/or an inferior wash-out period as stated as follows:
  • H1-receptor antagonists: fexofenadine (10 days prior to Day 0), loratadine, cetirizine, hydroxyzine, diphenhydramine, cyproheptadine, etc. (3 days prior to Day 0)
  • H2-receptor antagonists: cimetidine, ranitidine and famotidine (2 days prior to Day 0)
  • H1- and H2-receptor antagonists: doxepin (7 days prior to Day 0)
  • Leukotriene antagonists: zafirlukast and montelukast (4 days prior to Day 0)
  • Corticosteroids: prednisone and methylprednisolone (7 days prior to Day 0)
  • Tricyclic antidepressants: imipramin and amitriptilin (30 days prior to Day 0)
  • The informed consent form must be signed prior to any washout period is set up.
  • Physical urticaria due to cold, heat, and/or sun
  • Cholinergic urticaria
  • Patient taking any potential inhibitors of the CYP3A4 isozyme of cytochrome P450 such as ketoconazole, erythromycin and/or tricyclic antidepressants, e.g. imipramin, amitriptilin, etc.
  • Urticaria due to known aetiology (e.g., medications, insects bites, food, etc)
  • Patient unresponsive to antihistaminic treatment
  • Patient with psychiatric disorders, vascular, hepatic, neurological, endocrine or other major systemic disease
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Saint Louis

Paris, 75475, France

Location

Related Publications (1)

  • Dubertret L, Zalupca L, Cristodoulo T, Benea V, Medina I, Fantin S, Lahfa M, Perez I, Izquierdo I, Arnaiz E. Once-daily rupatadine improves the symptoms of chronic idiopathic urticaria: a randomised, double-blind, placebo-controlled study. Eur J Dermatol. 2007 May-Jun;17(3):223-8. doi: 10.1684/ejd.2007.0153. Epub 2007 May 4.

    PMID: 17478385RESULT

MeSH Terms

Conditions

Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • EVA Arnaiz, PhD

    J. Uriach y Compañía

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

October 28, 2002

Primary Completion

November 25, 2003

Study Completion

September 27, 2004

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

FR(1)