Post-nasal DripPhase 2NCT00816972
Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED)
A Phase 2 study testing Desloratadine 2.5 mg and Oxybutynin 2.5 mg in people with Post-nasal Drip and Seasonal Allergic Rhinitis, run by Organon and Co.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-nasal Drip, Seasonal Allergic Rhinitis, Rhinorrhea
- What is being tested?
- Desloratadine 2.5 mg and Oxybutynin 2.5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip
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.
- Conditions
- Post-nasal Drip, Seasonal Allergic Rhinitis, Rhinorrhea
- Being tested
- Desloratadine 2.5 mg, Oxybutynin 2.5 mg, Placebo for Desloratadine 2.5 mg, Placebo for Oxybutynin 2.5 mg
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine 2.5 mgDrug
Also called SCH 034117, Clarinex
Desloratadine 2.5 mg BID
Oxybutynin 2.5 mgDrug
Also called Ditropan
Oxybutynin 2.5 mg BID
Placebo for Desloratadine 2.5 mgDrug
Placebo BID
Placebo for Oxybutynin 2.5 mgDrug
Placebo BID
| Study group | Role | What they receive |
|---|---|---|
| DL 2.5 mg | Active comparator | Desloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days Receives: Drug: Desloratadine 2.5 mg; Drug: 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 Receives: Drug: Oxybutynin 2.5 mg; Drug: 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 Receives: Drug: Desloratadine 2.5 mg; Drug: Oxybutynin 2.5 mg; Drug: 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 Receives: Drug: Desloratadine 2.5 mg; Drug: Oxybutynin 2.5 mg |
| Placebo | Placebo comparator | Placebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days Receives: Drug: Placebo for Desloratadine 2.5 mg; Drug: Placebo for Oxybutynin 2.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean daily AM/PM Prior post-nasal drip scores averaged over the entire treatment period
Measured: Days 1 to 7 +/- 2 days
Secondary outcomes (1)
Anterior rhinorrhea averaged over Days 1 to 8
Measured: Days 1 to 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startApr 2005
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-nasal DripStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816972
- Sponsor's protocol ID
- P04258
- Status last verified
- Feb 2022
- First submitted
- 5 Jan 2009
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Efficacy and Safety Field Trial of Desloratadine Administered Concomitantly With Oxybutynin, in Subjects With Seasonal Allergic Rhinitis and Post-Nasal Drip
- ClinicalTrials.gov ID
- NCT00816972
- Acronym / sponsor ID
- P04258
- Conditions
- Post-nasal Drip, Seasonal Allergic Rhinitis, Rhinorrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| DL 2.5 mg | Active comparator | Drug: Desloratadine 2.5 mg, Drug: Placebo for Oxybutynin 2.5 mgDesloratadine 2.5 mg twice daily (BID) + Placebo for Oxybutynin 2.5 mg BID for 7 days |
| OXY 5 mg | Active comparator | Drug: Oxybutynin 2.5 mg, Drug: Placebo for Desloratadine 2.5 mgPlacebo for Desloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days |
| DL 2.5 mg + OXY 2.5 mg | Experimental | Drug: Desloratadine 2.5 mg, Drug: Oxybutynin 2.5 mg, Drug: Placebo for Oxybutynin 2.5 mgDesloratadine 2.5 mg BID + Oxybutynin 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days |
| DL 2.5 mg + OXY 5 mg | Experimental | Drug: Desloratadine 2.5 mg, Drug: Oxybutynin 2.5 mgDesloratadine 2.5 mg BID + Oxybutynin 5 mg BID for 7 days |
| Placebo | Placebo comparator | Drug: Placebo for Desloratadine 2.5 mg, Drug: Placebo for Oxybutynin 2.5 mgPlacebo for Desloratadine 2.5 mg BID + Placebo for Oxybutynin 2.5 mg BID for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desloratadine 2.5 mgAlso: SCH 034117, ClarinexDesloratadine 2.5 mg BID | Drug | DL 2.5 mg, DL 2.5 mg + OXY 2.5 mg, DL 2.5 mg + OXY 5 mg |
| Oxybutynin 2.5 mgAlso: DitropanOxybutynin 2.5 mg BID | Drug | DL 2.5 mg + OXY 2.5 mg, DL 2.5 mg + OXY 5 mg, OXY 5 mg |
| Placebo for Desloratadine 2.5 mgPlacebo BID | Drug | OXY 5 mg, Placebo |
| Placebo for Oxybutynin 2.5 mgPlacebo BID | Drug | DL 2.5 mg, DL 2.5 mg + OXY 2.5 mg, Placebo |
Primary outcome
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
1 secondary outcome
Anterior rhinorrhea averaged over Days 1 to 8
Time frame: Days 1 to 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desloratadine 2.5 mg and Oxybutynin 2.5 mg in people with Post-nasal Drip and Seasonal Allergic Rhinitis, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.