Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients
This study has been terminated.
(Study stopped due to low accrual)
Sponsor:
Alberta Health Services
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00351715
First received: July 11, 2006
Last updated: January 24, 2013
Last verified: October 2008
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Purpose
The purpose of this Phase II study is to determine the feasibility of the dose titration and assessment protocol in the outpatient population 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 optimal dose of sublingual (Under the tongue) methadone and then studied at that optimal dose with successive episodes of breakthrough pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Pain |
Drug: Sublingual Methadone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Sublingual Methadone for the Management of Cancer-related Breakthrough Pain in Outpatients: a Phase II Multicenter, Open Label, Feasibility Study |
Resource links provided by NLM:
Further study details as provided by Alberta Health Services:
Primary Outcome Measures:
- to demonstrate the feasibility of a novel model to assess sublingual methadone to breakthrough pain in the outpatient setting
Secondary Outcome Measures:
- to develop a model of PK/PD study of breakthrough pain
- to develop a research tool, the Breakthrough Pain Assessment Tool (BPAT)
- to demonstrate proof of concept
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pain due to cancer or its treatment; controlled baseline pain;
- episodes of breakthrough pain every day that are "4/10" in severity or greater, ;
- ast 10 minutes or longer, and
- are responsive to short acting oral opioids such as morphine or hydromorphone;
- are able to hole a volume of 1.0cc of water under the tongue for a 5-minute period; are able to provide written informed consent;
- are able to fill out the study forms
Exclusion Criteria:
- Severe underlying respiratory disease such that an investigator is wary about the risk of respiratory failure from modest doses of opioid;
- prior sensitivity to methadone;
- currently are being administered methadone;
- have breakthrough pain that in the opinion of the investigator is likely to change within the next seven days (recent or imminent radiation therapy to the main site of pain,
- new chemotherapy or use of an injectable bisphosphonate likely to alter the pain, new use corticosteroids within the past week with a corresponding change in pain, or other interventions judged likely to alter pain);
- are clinically unstable or have a life expectancy of less than one month making completion of the trial unlikely
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00351715
Locations
| Canada, Alberta | |
| Tom Baker Cancer Center | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada | |
Sponsors and Collaborators
Alberta Health Services
Investigators
| Principal Investigator: | Neil Hagen, MD | Alberta Health Services |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00351715 History of Changes |
| Other Study ID Numbers: | 20144, 22206 |
| Study First Received: | July 11, 2006 |
| Last Updated: | January 24, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Alberta Health Services:
|
Sublingual Methadone Cancer related breakthrough pain feasibility study Phase II/open label |
Outpatients Safety/ efficacy previously receiving opioids speak English |
Additional relevant MeSH terms:
|
Methadone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013