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Tracking Information | |||||
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First Received Date † | June 26, 2007 | ||||
Last Updated Date | February 8, 2008 | ||||
Start Date † | June 2007 | ||||
Current Primary Outcome Measures † |
pain intensity difference [ Time Frame: 60 minutes ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00492388 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
various pain assessments [ Time Frame: 60 minutes ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients | ||||
Official Title † | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Comparing the Efficacy and Safety of PMI-150 (Intranasal Ketamine) to Placebo as an Analgesic for the Treatment of Breakthrough Pain in Cancer Patients | ||||
Brief Summary | To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients. |
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Detailed Description | The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 90 | ||||
Estimated Completion Date | June 2009 | ||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00492388 | ||||
Responsible Party | Javelin Pharmaceuticals, Javelin Pharmaceuticals | ||||
Secondary IDs †† | |||||
Study Sponsor † | Javelin Pharmaceuticals | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Javelin Pharmaceuticals | ||||
Verification Date | February 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |