Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684AM2)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00405964
First received: November 30, 2006
Last updated: October 22, 2010
Last verified: October 2010
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Results First Received: March 25, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Allergic Rhinitis |
| Interventions: |
Drug: 5-mg Desloratadine Drug: Placebo tablet |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 5-mg Desloratadine Tablet | Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening. |
| Placebo Tablet | Matching placebo, orally daily. |
Participant Flow: Overall Study
| 5-mg Desloratadine Tablet | Placebo Tablet | |
|---|---|---|
| STARTED | 360 | 356 |
| COMPLETED | 301 | 261 |
| NOT COMPLETED | 59 | 95 |
| Treatment Failure | 17 | 45 |
| Adverse Event | 7 | 16 |
| Lost to Follow-up | 5 | 5 |
| Withdrawal by Subject | 19 | 23 |
| Protocol Violation | 11 | 6 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 5-mg Desloratadine Tablet | Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening. |
| Placebo Tablet | Matching placebo, orally daily. |
| Total | Total of all reporting groups |
Baseline Measures
| 5-mg Desloratadine Tablet | Placebo Tablet | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
360 | 356 | 716 |
|
Age
[units: participants] |
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| <=18 years | 9 | 9 | 18 |
| Between 18 and 65 years | 348 | 341 | 689 |
| >=65 years | 3 | 6 | 9 |
|
Age
[units: years] Mean ± Standard Deviation |
34.0 ± 12.1 | 33.9 ± 12.3 | 33.9 ± 12.2 |
|
Gender
[units: participants] |
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| Female | 208 | 198 | 406 |
| Male | 152 | 158 | 310 |
Outcome Measures
| 1. Primary: | Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment [ Time Frame: Baseline and Days 1-29 ] |
| 2. Secondary: | Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment [ Time Frame: Baseline and Day 29 ] |
| 3. Secondary: | Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment [ Time Frame: Baseline and Days 1-85 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
Results Point of Contact:
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00405964 History of Changes |
| Other Study ID Numbers: | P04684 |
| Study First Received: | November 30, 2006 |
| Results First Received: | March 25, 2009 |
| Last Updated: | October 22, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |