NCT00291642

Brief Summary

The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Unit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
551

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
12.3 years until next milestone

Results Posted

Study results publicly available

July 20, 2018

Completed
Last Updated

September 11, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

February 10, 2006

Results QC Date

October 10, 2017

Last Update Submit

August 13, 2018

Conditions

RhinitisAllergicSeasonal

Keywords

LevocetirizineXyzalRhinitisAllergicSeasonalRagweed

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I

    Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score: Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes. Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

    Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

Secondary Outcomes (8)

  • Change From Baseline in the MSC Score Over Period II

    Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]

  • Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)

    Baseline to Day 2

  • Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I

    Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]

  • Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II

    Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]

  • Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)

    Baseline to Day 2

  • +3 more secondary outcomes

Study Arms (5)

Placebo (PBO)

PLACEBO COMPARATOR

A single dose of placebo was administered orally on Day 1.

Drug: Placebo dropsDrug: Placebo tablets matching to levocetirizineDrug: Placebo tablets matching to cetirizine

Levocetirizine (LCTZ) 2.5 mg

EXPERIMENTAL

A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.

Drug: Levocetirizine drops

Levocetirizine (LCTZ) 5 mg

EXPERIMENTAL

A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.

Drug: Levocetirizine tablets

Cetirizine (CTZ) 5 mg

EXPERIMENTAL

A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.

Drug: Cetirizine drops

Cetirizine (CTZ) 10 mg

EXPERIMENTAL

A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.

Drug: Cetirizine tablets

Interventions

Placebo dropsDRUG

* Pharmaceutical form: Drops for oral administration * Route of administration: Oral use

Placebo (PBO)
Placebo tablets matching to levocetirizineDRUG

* Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use

Placebo (PBO)
Placebo tablets matching to cetirizineDRUG

* Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use

Placebo (PBO)
Levocetirizine dropsDRUG

* Pharmaceutical form: Drops for oral administration * Concentration: 5 mg/ml * Route of administration: Oral use

Also known as: Xyzal
Levocetirizine (LCTZ) 2.5 mg
Levocetirizine tabletsDRUG

* Pharmaceutical form: Tablets for oral administration * Concentration: 5 mg * Route of administration: Oral use

Also known as: Xyzal
Levocetirizine (LCTZ) 5 mg
Cetirizine dropsDRUG

* Pharmaceutical form: Drops for oral administration * Concentration: 10 mg/ml * Route of administration: Oral use

Cetirizine (CTZ) 5 mg
Cetirizine tabletsDRUG

* Pharmaceutical form: Tablets for oral administration * Concentration: 10 mg * Route of administration: Oral use

Cetirizine (CTZ) 10 mg

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study.
  • Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
  • Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol

You may not qualify if:

  • Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
  • Have used forbidden concomitant medications as defined by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kingston, Ontario, Canada

Location

Related Links

MeSH Terms

Conditions

Rhinitis

Interventions

levocetirizineCetirizine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
UCB
Organization
UCB S.A.
UCBCares@ucb.com
+1844 599

Study Officials

  • UCB Cares

    UCB (+1 844 599 2273)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 14, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

September 11, 2018

Results First Posted

July 20, 2018

Record last verified: 2018-08-01

Locations

CA(1)