Chronic Urticaria - Long Term Assessment of Effects of Rupatadine

NCT02358265 | Terminated Phase 3

• 1 other identifier: CU-LATER
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

To compare CSU disease activity at the end of the follow up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase

Conditions

Chronic Urticaria

Outcome Measures

Primary Outcomes (1)

• Urticaria Activity Score (7 day cummulative score - UAS7)

  The UAS daily quantifies wheals (0-3 points) and itching (0-3 points). Accordingly, the minimum and maximum value of the 7 day cumulative score (UAS7) is 0 and 42, respectively.

  1 week

Study Arms (4)

10 mg Rupatadine on demand

ACTIVE COMPARATOR

Rupatadine 10 mg, on demand

Drug: 10 mg Rupatadine on demand

10 mg Rupatadin

ACTIVE COMPARATOR

Rupatadine 10 mg, continuously

Drug: 10 mg Rupatadine

20 mg Rupatadine

ACTIVE COMPARATOR

Rupatadine 20 mg, continuously

Drug: 20 mg Rupatadine

10 mg rupatadine on demand (sham upd.)

ACTIVE COMPARATOR

Rupatadine 10 mg, on demand (sham updosing to 20 mg)

Drug: 10 mg Rupatadine on demand (sham updosing to 20 mg)

Interventions

10 mg Rupatadine on demand DRUG

Group A1 (dose administered: 10 mg rupatadine on demand): one tablet of placebo once daily- one on-demand tablet of rupatadine 10 mg intake only if needed.

10 mg Rupatadine on demand

10 mg Rupatadine DRUG

Group B1 (dose administered: 10 mg rupatadine continuously): one tablet of rupatadine 10 mg once daily, one on-demand tablet of placebo, intake only if needed.

10 mg Rupatadin

20 mg Rupatadine DRUG

Group B2 (dose administered: 10 mg rupatadine continuously): two tablets of rupatadine 10 mg daily- one on-demand tablet of placebo , intake only if needed.

20 mg Rupatadine

10 mg Rupatadine on demand (sham updosing to 20 mg) DRUG

Group A2 (dose administered: 10 mg rupatadine on demand): two tablets of placebo daily- one on-demand tablet of rupatadine 10 mg ,intake only if needed.

10 mg rupatadine on demand (sham upd.)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 years and older
• Documented history of active CSU (urticaria and wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to visit 1 (screening). Urticaria symptoms must comprise wheals and itch
• UAS7 of ≥6 during the screening phase
• Overall duration of chronic spontaneous urticaria for at least 3 months
• Informed consent signed and dated
• Able to read, understand and willing to sign the informed consent form and abide with study procedures
• Willing, committed and able to return for all clinic visits and complete all study-related procedures
• In females of childbearing potential: negative pregnancy test; females willing to use highly effective contraception (Pearl-Index \< 1) a woman will be considered not of childbearing potential if she is post-menopausal for \> 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
• No participation in other clinical trials 4 weeks before and after participation in this study

You may not qualify if:

• Chronic spontaneous urticaria patients with a known resistance to nsAH in 4 times the licensed doses
• Chronic spontaneous urticaria patients with a known resistance to rupatadine
• Isolated presence or domination of inducible forms of urticaria or cholinergic urticaria (no chronic spontaneous urticaria)
• History of adverse reactions to rupatadine or known hypersensitivity to rupatadine or its ingredients
• Intake of oral corticosteroids or intravenously applied corticosteroids within 28 days prior to screening visit
• Use of depot corticosteroids within 3 months prior to screening visit (inhaled corticosteroids are allowed)
• Use of systemic immunosupressants/immunomodulators such as ciclosporin, dapsone, metotrexate, and comparable drugs within 28 days prior to screening visit.
• Significant medical condition, in the opinion of the Investigator, rendering the patient immunocompromised or not suitable for a clinical trial
• Significant concomitant illness, in the opinion of the Investigator, that would adversely affect the subject's participation or evaluation in this study
• Subjects for whom there is concern, in the opinion of the Investigator, about compliance with the protocol procedures
• The presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
• Presence of active cancer which requires chemotherapy or radiation therapy
• History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
• History or presence of myocardial infarction or acute myocardial ischemia
• History or presence of cardiac arrhythmia which requires drug therapy

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Allergie-Centrum-Charite

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

rupatadine

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PD

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: February 6, 2015
• Study Start: December 1, 2014
• Primary Completion: November 20, 2017
• Study Completion: June 15, 2018
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

DE (1)