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Chronic Urticaria - Long Term Assessment of Effects of Rupatadine

NCT02358265 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2019-09-17

No results posted yet for this study

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

Interventions

DRUG

10 mg Rupatadine on demand

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.

DRUG

10 mg Rupatadine

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.

DRUG

20 mg Rupatadine

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.

DRUG

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

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.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-11-20
Completion
2018-06-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02358265 on ClinicalTrials.gov