Trial · NCT00405964
Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684)
NCT00405964, Phase 3, Completed, Organon and Co; results first posted 2010-11-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684). Trials, record NCT00405964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00405964
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684)
- NCT number
- NCT00405964
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 716 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Allergic Rhinitis
- Interventions
- 5-mg Desloratadine, Placebo tablet
- First posted
- 2006-12-04
- Last updated
- 2024-05-20
- Results first posted
- 2010-11-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment | Baseline and Days 1-29 | AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference. |
| Secondary | Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment | Baseline and Day 29 | The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference. |
| Secondary | Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment | Baseline and Days 1-85 | AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate AM and PM evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment | Baseline and Days 1-29 | All randomized participants | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment | Baseline and Day 29 | All randomized participants | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment | Baseline and Days 1-85 | All randomized participants | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment | 5-mg Desloratadine Tablet | Baseline | 9.63 | Standard Error 0.13 | units on a scale |
| Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment | Placebo Tablet | Baseline | 9.55 | Standard Error 0.12 | units on a scale |
| Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment | 5-mg Desloratadine Tablet | Days 1-29 | -3.76 | Standard Error 0.22 | units on a scale |
| Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment | Placebo Tablet | Days 1-29 | -2.87 | Standard Error 0.21 | units on a scale |
| Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment | 5-mg Desloratadine Tablet | Baseline | 3.30 | Standard Error 0.08 | units on a scale |
| Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment | Placebo Tablet | Baseline | 3.15 | Standard Error 0.08 | units on a scale |
| Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment | 5-mg Desloratadine Tablet | Day 29 | -1.35 | Standard Error 0.10 | units on a scale |
| Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment | Placebo Tablet | Day 29 | -0.95 | Standard Error 0.10 | units on a scale |
| Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment | 5-mg Desloratadine Tablet | Baseline | 9.63 | Standard Error 0.13 | units on a scale |
| Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment | Placebo Tablet | Baseline | 9.55 | Standard Error 0.12 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5-mg Desloratadine Tablet | 360 | |
| Overall Study | STARTED | Placebo Tablet | 356 | |
| Overall Study | COMPLETED | 5-mg Desloratadine Tablet | 301 | |
| Overall Study | COMPLETED | Placebo Tablet | 261 | |
| Overall Study | NOT COMPLETED | 5-mg Desloratadine Tablet | 59 | |
| Overall Study | NOT COMPLETED | Placebo Tablet | 95 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | 5-mg Desloratadine Tablet | 38 | 360 | 44 |
| other | Nasopharyngitis | Infections and infestations | Placebo Tablet | 17 | 356 | 18 |
| other | Headache | Nervous system disorders | 5-mg Desloratadine Tablet | 25 | 360 | 45 |
| other | Headache | Nervous system disorders | Placebo Tablet | 37 | 356 | 63 |
| serious | Acute Myocardial Infarction | Cardiac disorders | 5-mg Desloratadine Tablet | 0 | 360 | 0 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Placebo Tablet | 1 | 356 | 1 |
| serious | Diverticulum Intestinal | Gastrointestinal disorders | 5-mg Desloratadine Tablet | 0 | 360 | 0 |
| serious | Diverticulum Intestinal | Gastrointestinal disorders | Placebo Tablet | 1 | 356 | 1 |
| serious | Lower Limb Fracture | Injury, poisoning and procedural complications | 5-mg Desloratadine Tablet | 1 | 360 | 1 |
| serious | Lower Limb Fracture | Injury, poisoning and procedural complications | Placebo Tablet | 0 | 356 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5-mg Desloratadine Tablet | ||
| Total, all-cause mortality | Placebo Tablet | ||
| Total, other adverse events | 5-mg Desloratadine Tablet | 60 | 360 |
| Total, other adverse events | Placebo Tablet | 48 | 356 |
| Total, serious adverse events | 5-mg Desloratadine Tablet | 1 | 360 |
| Total, serious adverse events | Placebo Tablet | 2 | 356 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 5-mg Desloratadine Tablet vs Placebo Tablet: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00405964
GET https://conductscience.org/api/trials/v1/NCT00405964/registered