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Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)

Primary Purpose

Post-nasal Drip, Seasonal Allergic Rhinitis, Rhinorrhea

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Desloratadine 2.5 mg

Oxybutynin 2.5 mg

Placebo for Desloratadine 2.5 mg

Placebo for Oxybutynin 2.5 mg

About this trial

This is an interventional treatment trial for Post-nasal Drip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must:

be >=18 years of age,
be free of any clinically significant disease that would interfere with study, other than seasonal allergic rhinitis (SAR),
have a documented diagnosis of SAR for >=2 years,
have had a positive skin-prick test,
be sufficiently symptomatic at the Screening visit,
for the 3 calendar days immediately prior to baseline visit, plus the AM of the baseline visit, the seven twice-daily run-in diary PRIOR total nasal symptom scores must have totaled >=42, the Total Non-Nasal Symptoms score must have totaled >=28, and the total Post Nasal Drip score must have totaled >=14,
be in general good health.

Exclusion Criteria:

Subjects who have:

certain medical conditions or medical histories,
allergies to any of the components in any of the study medications,
nasal structure abnormalities,
dependency to nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids,
used any investigational drug use in past 30 days,
received immunotherapy (desensitization)
are pregnant

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

DL 2.5 mg

OXY 5 mg

DL 2.5 mg + OXY 2.5 mg

DL 2.5 mg + OXY 5 mg

Placebo

Arm Description

Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days

Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days

Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days

Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days

Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days

Outcomes

Primary Outcome Measures

Change from baseline in mean daily AM/PM Prior post-nasal drip scores averaged over the entire treatment period

Secondary Outcome Measures

Anterior rhinorrhea averaged over Days 1 to 8

Full Information

NCT ID

NCT00816972

First Posted

January 5, 2009

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00816972

Brief Title

Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)

Official Title

Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

April 2005 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This was a 1-week study of desloratadine (DL) plus oxybutynin (OXY) at two dose levels in the treatment of post-nasal drip in participants with seasonal allergic rhinitis. Participants received either desloratadine twice a day, oxybutynin twice a day, desloratadine plus lower-dose oxybutynin twice a day, desloratadine plus higher-dose oxybutynin twice a day, or placebo for 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-nasal Drip, Seasonal Allergic Rhinitis, Rhinorrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

540 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DL 2.5 mg

Arm Type

Active Comparator

Arm Description

Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days

Arm Title

OXY 5 mg

Arm Type

Active Comparator

Arm Description

Placebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days

Arm Title

DL 2.5 mg + OXY 2.5 mg

Arm Type

Experimental

Arm Description

Desloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days

Arm Title

DL 2.5 mg + OXY 5 mg

Arm Type

Experimental

Arm Description

Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days

Intervention Type

Drug

Intervention Name(s)

Desloratadine 2.5 mg

Other Intervention Name(s)

SCH 034117, Clarinex

Intervention Description

Desloratadine 2.5 mg BID

Intervention Type

Drug

Intervention Name(s)

Oxybutynin 2.5 mg

Other Intervention Name(s)

Ditropan

Intervention Description

Oxybutynin 2.5 mg BID

Intervention Type

Drug

Intervention Name(s)

Placebo for Desloratadine 2.5 mg

Intervention Description

Placebo BID

Intervention Type

Drug

Intervention Name(s)

Placebo for Oxybutynin 2.5 mg

Intervention Description

Placebo BID

Primary Outcome Measure Information:

Title

Change from baseline in mean daily AM/PM Prior post-nasal drip scores averaged over the entire treatment period

Time Frame

Days 1 to 7 +/- 2 days

Secondary Outcome Measure Information:

Title

Anterior rhinorrhea averaged over Days 1 to 8

Time Frame

Days 1 to 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must: be >=18 years of age, be free of any clinically significant disease that would interfere with study, other than seasonal allergic rhinitis (SAR), have a documented diagnosis of SAR for >=2 years, have had a positive skin-prick test, be sufficiently symptomatic at the Screening visit, for the 3 calendar days immediately prior to baseline visit, plus the AM of the baseline visit, the seven twice-daily run-in diary PRIOR total nasal symptom scores must have totaled >=42, the Total Non-Nasal Symptoms score must have totaled >=28, and the total Post Nasal Drip score must have totaled >=14, be in general good health. Exclusion Criteria: Subjects who have: certain medical conditions or medical histories, allergies to any of the components in any of the study medications, nasal structure abnormalities, dependency to nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, used any investigational drug use in past 30 days, received immunotherapy (desensitization) are pregnant

12. IPD Sharing Statement

Learn more about this trial

Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)

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