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

Sponsored by:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00492388

Purpose

To assess the safety and efficacy of PMI-150 (Intranasal Ketamine) as an analgesic for the treatment of breakthrough pain in cancer patients.

Condition	Intervention	Phase
Pain Cancer	Drug: PMI-150 (intranasal ketamine) Drug: placebo	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Ketamine Ketamine hydrochloride

U.S. FDA Resources

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

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:

pain intensity difference [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

various pain assessments [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental PMI-150 (intranasal ketamine)	Drug: PMI-150 (intranasal ketamine) intranasal dosing
B: Placebo Comparator placebo	Drug: placebo placebo

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492388

Contacts

Contact: Robyn Squire

617-667-5729

rsquire@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Javelin Pharmaceuticals

Investigators

Principal Investigator:

Zahid Bajwa, MD

Beth Israel Deaconess Medical Center

More Information

Responsible Party:	Javelin Pharmaceuticals ( Javelin Pharmaceuticals )
Study ID Numbers:	KET-016
Study First Received:	June 26, 2007
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00492388
Health Authority:	United States: Food and Drug Administration

Keywords provided by Javelin Pharmaceuticals:

breakthrough
pain
cancer

Study placed in the following topic categories:

Excitatory Amino Acids
Ketamine
Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative

Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009