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
18 Years
N/A
Both
Pain, Cancer
Trial Information
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
The primary objective is to evaluate the safety and efficacy following the administration of
intranasal ketamine in providing pain relief as compared to placebo.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
pain intensity difference
Outcome Time Frame:
60 minutes
Safety Issue:
No
Principal Investigator
Zahid Bajwa, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beth Israel Deaconess Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
KET-016
NCT ID:
NCT00492388
Start Date:
June 2007
Completion Date:
August 2011
Related Keywords:
- Pain
- Cancer
- breakthrough
- pain
- cancer
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
