Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients
This study has been terminated.
(Business decision not to continue development)
Sponsor:
Hospira, Inc.
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00492388
First received: June 26, 2007
Last updated: January 10, 2012
Last verified: January 2012
| Tracking Information | |||||
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| First Received Date ICMJE | June 26, 2007 | ||||
| Last Updated Date | January 10, 2012 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
pain intensity difference [ Time Frame: 60 minutes ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
pain intensity difference [ Time Frame: 60 minutes ] | ||||
| Change History | Complete list of historical versions of study NCT00492388 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
various pain assessments [ Time Frame: 60 minutes ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
various pain assessments [ Time Frame: 60 minutes ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients | ||||
| Official Title ICMJE | 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 Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 2 | ||||
| Completion Date | August 2011 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00492388 | ||||
| Other Study ID Numbers ICMJE | KET-016 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Hospira, Inc. | ||||
| Study Sponsor ICMJE | Hospira, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospira, Inc. | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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