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

NCT ID: NCT00492388

Last Updated: 2012-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-08-31

Brief Summary

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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

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The primary objective is to evaluate the safety and efficacy following the administration of intranasal ketamine in providing pain relief as compared to placebo.

Conditions

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Pain Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

PMI-150 (intranasal ketamine)

Group Type EXPERIMENTAL

PMI-150 (intranasal ketamine)

Intervention Type DRUG

intranasal dosing

B

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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PMI-150 (intranasal ketamine)

intranasal dosing

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zahid Bajwa, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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KET-016

Identifier Type: -

Identifier Source: org_study_id

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