NCT00816972

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
540

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2

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

April 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

January 5, 2009

Last Update Submit

February 7, 2022

Conditions

Post-nasal DripSeasonal Allergic RhinitisRhinorrhea

Outcome Measures

Primary Outcomes (1)

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

    Days 1 to 7 +/- 2 days

Secondary Outcomes (1)

  • Anterior rhinorrhea averaged over Days 1 to 8

    Days 1 to 8

Study Arms (5)

DL 2.5 mg

ACTIVE COMPARATOR

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

Drug: Desloratadine 2.5 mgDrug: Placebo for Oxybutynin 2.5 mg

OXY 5 mg

ACTIVE COMPARATOR

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

Drug: Oxybutynin 2.5 mgDrug: Placebo for Desloratadine 2.5 mg

DL 2.5 mg + OXY 2.5 mg

EXPERIMENTAL

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

Drug: Desloratadine 2.5 mgDrug: Oxybutynin 2.5 mgDrug: Placebo for Oxybutynin 2.5 mg

DL 2.5 mg + OXY 5 mg

EXPERIMENTAL

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

Drug: Desloratadine 2.5 mgDrug: Oxybutynin 2.5 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo for Desloratadine 2.5 mgDrug: Placebo for Oxybutynin 2.5 mg

Interventions

Desloratadine 2.5 mgDRUG

Desloratadine 2.5 mg BID

Also known as: SCH 034117, Clarinex
DL 2.5 mgDL 2.5 mg + OXY 2.5 mgDL 2.5 mg + OXY 5 mg
Oxybutynin 2.5 mgDRUG

Oxybutynin 2.5 mg BID

Also known as: Ditropan
DL 2.5 mg + OXY 2.5 mgDL 2.5 mg + OXY 5 mgOXY 5 mg
Placebo for Desloratadine 2.5 mgDRUG

Placebo BID

OXY 5 mgPlacebo
Placebo for Oxybutynin 2.5 mgDRUG

Placebo BID

DL 2.5 mgDL 2.5 mg + OXY 2.5 mgPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinorrhea

Interventions

desloratadineoxybutynin

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

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

January 5, 2009

First Posted

January 6, 2009

Study Start

April 1, 2005

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

February 16, 2022

Record last verified: 2022-02