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A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK835726 (10mg) | Active Comparator | 10mg oral dose |
|
| GSK835726 (50mg) | Active Comparator | 50mg oral dose |
|
| GSK835726 (100mg) | Active Comparator | 50mg oral dose |
|
| Cetirizine 10mg | Active Comparator | 10mg cetirizine as active comparator |
|
| placebo | Placebo Comparator | placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK835726 (10mg) | Drug | GSK835726 (10mg) tablet |
| |
| GSK835726 (50mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total nasal symptom score 0-4 hours post dose | 0-4 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22212854 | Background | Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H(1)/H(3) receptor antagonists in seasonal allergic rhinitis. Int Arch Allergy Immunol. 2012;158(1):84-98. doi: 10.1159/000329738. Epub 2011 Dec 29. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 110163 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 16, 2017 | |
| Reset | Nov 13, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 16, 2017 | Nov 13, 2017 |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C558852 | GSK 835726 |
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
GSK835726 (50mg) tablet |
|
| GSK835726 (100mg) | Drug | GSK835726 (100mg) tablet |
|
| Cetirizine (10mg) | Drug | Cetirizine (10mg) tablet as positive control |
|
| Placebo | Other | Placebo to match active |
|
For additional information about this study please refer to the GSK Clinical Study Register |
| 110163 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110163 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110163 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110163 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110163 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 110163 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |