Sublingual methadone for the management of cancer-related procedural pain in inpatients

Phase 2

Completed

• Conditions: Cancer-related breakthrough pain; Cancer; Pain, cancer

• Registration Number: ISRCTN72738824
• Lead Sponsor: Alberta Cancer Board (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-06
• Study Completion: 2007-12-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Pain due to cancer or its treatment
2. Controlled baseline pain
3. Episodes of predictable, treatment-related pain every day that are 4/10 in severity or greater, last ten 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
4. Able to hold a volume of 1.0 cc of water under the tongue for a two-minute period
5. Able to provide written, informed consent
6. Able to fill out the study forms, and must be an inpatient

Exclusion Criteria

1. Severe underlying respiratory disease such that the investigator is wary about the risk of respiratory failure from modest doses of opioid
2. Prior sensitivity to methadone
3. Currently taking methadone
4. Clinically unstable or a life expectancy of less than one month making completion of the trial unlikely
5. Patients who do not have an understanding of English enough to provide written, informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The primary objective of this current phase II study is to demonstrate the feasibility of a novel model to assess sublingual methadone to relieve iatrogenic, treatment-related incident breakthrough pain.<br><br> Specific aspects of feasibility are:<br> 1. To demonstrate the feasibility of recruitment to a study for incident pain in the inpatient setting<br> 2. Feasibility of dose titration in the inpatient setting<br> 3. Feasibility of filling out the pain assessments<br> 4. Provide preliminary evidence of efficacy<br> 5. To provide further information to document safety of the model<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. To develop a model of pharmacokinetic (PK) or pharmacodynamic (PD) study of breakthrough pain<br> 2. To develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)<br> 3. To demonstrate proof of concept, with half of patients obtaining meaningful pain reduction within five minutes of administration, when given the identified optimal dose<br>