Safety and Efficacy of PMI-150 (Intranasal Ketamine) for the Treatment of Breakthrough Pain in Cancer Patients

Tracking Information
First Submitted Date ICMJE	June 26, 2007
First Posted Date ICMJE	June 27, 2007
Last Update Posted Date	January 11, 2012
Study Start Date ICMJE	June 2007
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 26, 2007)	pain intensity difference [ Time Frame: 60 minutes ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00492388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 26, 2007)	various pain assessments [ Time Frame: 60 minutes ]
Original Secondary Outcome Measures ICMJE	Same as current
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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Pain; Cancer
Intervention ICMJE	Drug: PMI-150 (intranasal ketamine) intranasal dosing; Drug: placebo placebo
Study Arms	Experimental: A PMI-150 (intranasal ketamine) Intervention: Drug: PMI-150 (intranasal ketamine); Placebo Comparator: B placebo Intervention: Drug: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: January 10, 2012)	2
Original Estimated Enrollment ICMJE; (submitted: June 26, 2007)	90
Actual Study Completion Date	August 2011
Actual Primary Completion Date	August 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: at least 18 years of age; Patients requiring around-the-clock opioids for pain due to cancer and with a history of experiencing episodes of breakthrough pain Exclusion Criteria: under 18 years; non-cancer pain; allergy to ketamine
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Hospira, now a wholly owned subsidiary of Pfizer
Study Sponsor ICMJE	Hospira, now a wholly owned subsidiary of Pfizer
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Zahid Bajwa, MD Beth Israel Deaconess Medical Center
PRS Account	Hospira, now a wholly owned subsidiary of Pfizer
Verification Date	January 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP