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This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PART 1-Visit 1-Placebo | Placebo Comparator | Eligible subjects will receive matching placebo tablets |
|
| PART 1-Visit 1-Capsaicin | Experimental | Eligible subjects will receive incremental capsaicin doses |
|
| PART 1-Visit 2-Placebo | Placebo Comparator | Eligible subjects will receive matching placebo tablets |
|
| PART 1-Visit 2-Capsaicin | Experimental | Eligible subjects will receive maximum capsaicin dose |
|
| PART 1-Visit 3-Placebo | Placebo Comparator | Eligible subjects will receive matching placebo tablets |
|
| PART 1-Visit 3-Capsaicin | Experimental | Eligible subjects will receive matching placebo tablets incremental capsaicin doses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-705498 | Drug | Subjects will be administered a single dose of 400 mg SB-705498 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom scores and secretion weights | up to 83 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak nasal inspiratory flow changes after challenge | up to 83 days | |
| Biomarkers levels in the nasal samples | up to 83 days | |
| Blood levels of drug |
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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 | Amsterdam | 1105 AZ | Netherlands |
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| Label | URL |
|---|---|
| Results for study 111611 can be found on the GSK Clinical Study Register. | View source |
| 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 |
|---|---|---|---|
| 111611 | Study Protocol | 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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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C512301 | SB 705498 |
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|
| PART 2-Visit 1-Placebo | Placebo Comparator | Eligible subjects will receive matching placebo tablets |
|
| PART 2-Visit 1-SB-705498 | Experimental | Eligible subjects will receive SB-705498 tablets |
|
| PART 2-Visit 2-Capsaicin | Experimental | Eligible subjects will receive matching placebo tablets incremental capsaicin doses |
|
| Placebo | Drug | Subjects will be administered SB-705498 matching placebo tablets |
|
| Caspaicin | Other | Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose |
|
| up to 83 days |
| Pharmacodynamic response | up to 83 days |
| Safety parameters | up to 83 days |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111611 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111611 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111611 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111611 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111611 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111611 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D010038 |
| Otorhinolaryngologic Diseases |