Trial · NCT01700192
Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
NCT01700192, Phase 3, Completed, ALK-Abelló A/S; results first posted 2017-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607). Trials, record NCT01700192. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01700192
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
- NCT number
- NCT01700192
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,482 participants, actual
- Lead sponsor
- ALK-Abelló A/S
- Conditions
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Nonseasonal
- Interventions
MK-8237 tablets, Placebo tablets, Rescue Medication: Self-Injectable Epinephrine, Rescue Medication: Loratadine tablets, Rescue Medication: Olopatadine ophthalmic drops, Rescue Medication: Mometasone furoate nasal spray
- First posted
- 2012-10-04
- Last updated
- 2017-09-15
- Results first posted
- 2017-03-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. |
| Primary | Number of Participants Who Experience At Least One Adverse Event (AE) | Up to 54 weeks | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Primary | Number of Participants Who Discontinue Study Drug Due to an AE | Up to 52 weeks | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Secondary | Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. |
| Secondary | Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. |
| Secondary | Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. |
| Secondary | Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Score on a Scale | MEAN |
| PRIMARY | Number of Participants Who Experience At Least One Adverse Event (AE) | Up to 54 weeks | The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received). | Participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinue Study Drug Due to an AE | Up to 52 weeks | The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received). | Participants | NUMBER |
| SECONDARY | Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Score on a Scale | MEAN |
| SECONDARY | Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Score on a Scale | MEAN |
| SECONDARY | Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Score on a Scale | MEAN |
| SECONDARY | Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment | Last 8 weeks of treatment (Weeks 44 to 52) | The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available. | Score on a Scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment | MK-8237 | 4.67 | Standard Deviation 3.55 | Score on a Scale | |
| Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment | Placebo | 5.49 | Standard Deviation 3.82 | Score on a Scale | |
| Number of Participants Who Experience At Least One Adverse Event (AE) | MK-8237 | 676 | Participants | ||
| Number of Participants Who Experience At Least One Adverse Event (AE) | Placebo | 539 | Participants | ||
| Number of Participants Who Discontinue Study Drug Due to an AE | MK-8237 | 73 | Participants | ||
| Number of Participants Who Discontinue Study Drug Due to an AE | Placebo | 19 | Participants | ||
| Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment | MK-8237 | 3.83 | Standard Deviation 2.64 | Score on a Scale | |
| Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment | Placebo | 4.46 | Standard Deviation 2.80 | Score on a Scale | |
| Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment | MK-8237 | 0.84 | Standard Deviation 1.817 | Score on a Scale | |
| Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment | Placebo | 1.03 | Standard Deviation 2.074 | Score on a Scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-8237 | 741 | |
| Overall Study | STARTED | Placebo | 741 | |
| Overall Study | Treated | MK-8237 | 740 | |
| Overall Study | Treated | Placebo | 741 | |
| Overall Study | All Participants as Treated (APaT) | MK-8237 | 743 | |
| Overall Study | All Participants as Treated (APaT) | Placebo | 738 | |
| Overall Study | COMPLETED | MK-8237 | 561 | |
| Overall Study | COMPLETED | Placebo | 613 | |
| Overall Study | NOT COMPLETED | MK-8237 | 180 | |
| Overall Study | NOT COMPLETED | Placebo | 128 |
Source ClinicalTrials.gov
Adverse events82
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 | MK-8237 12 DU | 382 | 743 | 1,637 |
| other | Ear pruritus | Ear and labyrinth disorders | Placebo | 92 | 738 | 244 |
| other | Abdominal pain upper | Gastrointestinal disorders | MK-8237 12 DU | 92 | 743 | 212 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 44 | 738 | 87 |
| other | Diarrhoea | Gastrointestinal disorders | MK-8237 12 DU | 55 | 743 | 85 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 27 | 738 | 42 |
| other | Glossodynia | Gastrointestinal disorders | MK-8237 12 DU | 119 | 743 | 296 |
| other | Glossodynia | Gastrointestinal disorders | Placebo | 26 | 738 | 58 |
| other | Lip swelling | Gastrointestinal disorders | MK-8237 12 DU | 140 | 743 | 353 |
| other | Lip swelling | Gastrointestinal disorders | Placebo | 19 | 738 | 42 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-8237 12 DU | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | MK-8237 12 DU | 642 | 743 |
| Total, other adverse events | Placebo | 389 | 738 |
| Total, serious adverse events | MK-8237 12 DU | 11 | 743 |
| Total, serious adverse events | Placebo | 7 | 738 |
Source ClinicalTrials.gov
Papers5
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MK-8237 vs Placebo: Number of Participants Who Discontinue Study Drug Due to an AE | Trial comparisons |
| MK-8237 vs Placebo: Number of Participants Who Experience At Least One Adverse Event (AE) | Trial comparisons |
| MK-8237 12 DU vs Placebo: serious adverse events | 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/NCT01700192
GET https://conductscience.org/api/trials/v1/NCT01700192/events?page=2