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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

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.

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 Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^†

Pain
Cancer

Intervention ^†

Drug: PMI-150 (intranasal ketamine)
Drug: placebo

Study Arms / Comparison Groups

Experimental: PMI-150 (intranasal ketamine)
Placebo Comparator: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Robyn Squire

617-667-5729

rsquire@bidmc.harvard.edu

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 ^†

Principal Investigator:

Zahid Bajwa, MD

Beth Israel Deaconess Medical Center

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.