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| Descriptive Information Fields | |||||
| Brief Title † | Dose Response and Efficacy of GW842166 in Pain | ||||
| Official Title † | A Phase I, Placebo Controlled, Randomised, Double Blind Two-Way Crossover Study to Investigate the Dose Response and Efficacy of Single and Repeat Doses of GW842166 in Healthy Volunteers Using Pharmacodynamic Pain Assessments. | ||||
| Brief Summary | The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | • Heat pain threshold at 5 hours post dose [ Time Frame: 5 Hours ] | ||||
| Secondary Outcome Measure † | • Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose. [ Time Frame: 5 Hours ] | ||||
| Condition † | Healthy Volunteers | ||||
| Intervention † | Drug: GW842166X | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 0 | ||||
| Start Date † | November 2007 | ||||
| Completion Date | March 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00554762 | ||||
| Organization ID | CBA110877 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | GlaxoSmithKline | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | November 5, 2007 | ||||
| Last Updated Date | June 12, 2008 | ||||