Trial · NCT01385371
A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)
NCT01385371, Phase 3, Completed, ALK-Abelló A/S; results first posted 2013-09-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067). Trials, record NCT01385371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01385371
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of SCH 697243 in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma (P08067)
- NCT number
- NCT01385371
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,501 participants, actual
- Lead sponsor
- ALK-Abelló A/S
- Conditions
- Rhinitis Allergic, Conjunctivitis
- Interventions
- Grass (Phleum pratense) pollen allergen extract, Placebo for SCH 697243
- First posted
- 2011-06-30
- Last updated
- 2017-03-03
- Results first posted
- 2013-09-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS) | Entire GPS (expected average duration of 5 to 6 weeks) | The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. |
| Secondary | Average Rhinoconjunctivitis DSS Over the Entire GPS | Entire GPS (expected average duration of 5 to 6 weeks) | For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. |
| Secondary | Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS | Peak GPS (expected average duration of 2 weeks) | The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. |
| Secondary | Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS | Peak GPS (expected average duration of 2 weeks) | The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 \[mean of all domain scores\]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis. |
| Secondary | Average Rhinoconjunctivitis DMS Over the Entire GPS | Entire GPS (expected average duration of 5 to 6 weeks) | For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. |
| Secondary | Average Rhinoconjunctivitis DSS Over the Peak GPS | Peak GPS (expected average duration of 2 weeks) | For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. |
| Secondary | Average Rhinoconjunctivitis DMS Over the Peak GPS | Peak GPS (expected average duration of 2 weeks) | For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. |
| Secondary | Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age) | Peak GPS (expected average duration of 2 weeks) | For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 \[mean of all domain scores\]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS) | Entire GPS (expected average duration of 5 to 6 weeks) | The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | score on a scale | MEDIAN |
| SECONDARY | Average Rhinoconjunctivitis DSS Over the Entire GPS | Entire GPS (expected average duration of 5 to 6 weeks) | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | score on a scale | MEDIAN |
| SECONDARY | Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS | Peak GPS (expected average duration of 2 weeks) | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | score on a scale | MEDIAN |
| SECONDARY | Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS | Peak GPS (expected average duration of 2 weeks) | The FAS population consisted of all randomized participants ≥12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | score on a scale | MEDIAN |
| SECONDARY | Average Rhinoconjunctivitis DMS Over the Entire GPS | Entire GPS (expected average duration of 5 to 6 weeks) | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | score on a scale | MEAN |
| SECONDARY | Average Rhinoconjunctivitis DSS Over the Peak GPS | Peak GPS (expected average duration of 2 weeks) | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | score on a scale | MEDIAN |
| SECONDARY | Average Rhinoconjunctivitis DMS Over the Peak GPS | Peak GPS (expected average duration of 2 weeks) | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | score on a scale | MEAN |
| SECONDARY | Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age) | Peak GPS (expected average duration of 2 weeks) | The FAS population consisted of all randomized participants \<12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.entry. | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS) | SCH 697243 | 3.24 | Full Range 0.00 to 24.10 | score on a scale | |
| Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS) | Placebo | 4.22 | Full Range 0.00 to 23.16 | score on a scale | |
| Average Rhinoconjunctivitis DSS Over the Entire GPS | SCH 697243 | 2.49 | Full Range 0.00 to 18.00 | score on a scale | |
| Average Rhinoconjunctivitis DSS Over the Entire GPS | Placebo | 3.13 | Full Range 0.00 to 17.67 | score on a scale | |
| Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS | SCH 697243 | 3.33 | Full Range 0.00 to 30.88 | score on a scale | |
| Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS | Placebo | 4.67 | Full Range 0.00 to 34.21 | score on a scale | |
| Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS | SCH 697243 | 0.93 | Full Range 0.00 to 6.00 | score on a scale | |
| Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS | Placebo | 1.06 | Full Range 0.00 to 4.95 | score on a scale | |
| Average Rhinoconjunctivitis DMS Over the Entire GPS | SCH 697243 | 0.88 | Standard Error 0.11 | score on a scale | |
| Average Rhinoconjunctivitis DMS Over the Entire GPS | Placebo | 1.36 | Standard Error 0.16 | score on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SCH 697243 | 752 | |
| Overall Study | STARTED | Placebo | 749 | |
| Overall Study | COMPLETED | SCH 697243 | 603 | |
| Overall Study | COMPLETED | Placebo | 652 | |
| Overall Study | NOT COMPLETED | SCH 697243 | 149 | |
| Overall Study | NOT COMPLETED | Placebo | 97 |
Source ClinicalTrials.gov
Adverse events78
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 | Ear pruritus | Ear and labyrinth disorders | SCH 697243 | 92 | 753 | 108 |
| other | Ear pruritus | Ear and labyrinth disorders | Placebo | 12 | 745 | 13 |
| other | Lip swelling | Gastrointestinal disorders | SCH 697243 | 46 | 753 | 61 |
| other | Lip swelling | Gastrointestinal disorders | Placebo | 5 | 745 | 5 |
| other | Oedema mouth | Gastrointestinal disorders | SCH 697243 | 98 | 753 | 126 |
| other | Oedema mouth | Gastrointestinal disorders | Placebo | 9 | 745 | 10 |
| other | Oral pruritus | Gastrointestinal disorders | SCH 697243 | 139 | 753 | 171 |
| other | Oral pruritus | Gastrointestinal disorders | Placebo | 21 | 745 | 24 |
| other | Paraesthesia oral | Gastrointestinal disorders | SCH 697243 | 92 | 753 | 152 |
| other | Paraesthesia oral | Gastrointestinal disorders | Placebo | 24 | 745 | 28 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SCH 697243 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | SCH 697243 | 480 | 753 |
| Total, other adverse events | Placebo | 316 | 745 |
| Total, serious adverse events | SCH 697243 | 14 | 753 |
| Total, serious adverse events | Placebo | 9 | 745 |
Source ClinicalTrials.gov
Papers3
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 |
|---|
| SCH 697243 vs Placebo: 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/NCT01385371
GET https://conductscience.org/api/trials/v1/NCT01385371/events?page=2