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

• ClinicalTrials.gov Identifier: NCT00492388
• Recruitment Status: Terminated
• First Posted: June 27, 2007
• Last Update Posted: January 11, 2012
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Hospira, now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: June 26, 2007
• First Posted Date: June 27, 2007
• Last Update Posted Date: January 11, 2012
• Study Start Date: June 2007
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 26, 2007): pain intensity difference [ Time Frame: 60 minutes ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 26, 2007): various pain assessments [ Time Frame: 60 minutes ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

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.
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Pain
• Cancer

Intervention

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 10, 2012): 2
• Original Estimated Enrollment (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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00492388
• Other Study ID Numbers: KET-016
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
• Original Responsible Party: Not Provided
• Current Study Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
• Original Study Sponsor: Javelin Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Principal Investigator: Zahid Bajwa, MD; Beth Israel Deaconess Medical Center

• PRS Account: Hospira, now a wholly owned subsidiary of Pfizer
• Verification Date: January 2012