Sublingual Methadone for the Management of Cancer-related Procedure Pain in Inpatients

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

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the impatient population, in the clinical setting of preventing or managing breakthrough pain, before conducting an appropriately powered phase III study. Thus the primary purpose of this study is to determine the proportion of patients who are successfully titrated to an effective dose of sublingual methadone.

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Detailed Description

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Conditions

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Cancer Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sublingual Methadone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pain due to cancer or its treatment; Controlled baseline pain; episodes of predictable, treatment related pain every day that are 4"/10" in severity or greater, last 10 minutes or longer, or episodes of breakthrough pain not related to cancer treatment, and are responsive to short acting oral opioids such as morphine or hydromorphone; are able to hold a volume of 1.0cc of water under tongue for a 2-minute period; are able to provide written informed consent; are able to fill out the study forms, and are inpatients

Exclusion Criteria

* Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses od opioid; prior sensitivity to methadone; currently are being administered methadone; are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely; and if they do not understand English sufficiently to provide written informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No