Sublingual Methadone for the Management of Cancer Breakth... | NCT00125294

Studies
Sublingual Methadone for the Management of Cancer Breakthrough Pain

NCT00125294

Sponsor

AHS Cancer Control Alberta

Status

Completed

Last Update Posted

Sep 25, 2017Actual

Enrollment

10Actual

Phase

Phase 1

Conditions

Cancer
Pain

Interventions

Methadone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Calgary Health Region

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Jun 2006Actual

Completion Date

Jan 2007Actual

First Submitted Date

Jul 29, 2005

First Submission Date that Met QC Criteria

Jul 29, 2005

First Posted Date

Aug 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2017

Last Update Posted Date

Sep 25, 2017Actual

Name	Class
Calgary Health Region	OTHER

Description Module

Brief Summary

A dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.

Detailed Description

This is a dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Name	Type	Description	Arm Group Labels	Other Names
Methadone	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine optimal dose titration
Determine assessment protocol

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years of age
Experiences episodes of breakthrough pain which respond to opioid therapy
Controlled baseline pain
Cognitive status sufficient for accurate completion of assessment form
Willing to provide written informed consent
Ability to hold a volume of 1 cc of water under the tongue for 5 minutes

Exclusion Criteria:

Currently or has received methadone during the previous week
Recent history of substance abuse
Severe respiratory impairment or other contraindications to opioids
Recently received therapies that had the potential to alter pain intensity or response to analgesics
Symptomatic anemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Neil Hagen	Alberta Cancerboard	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D010146	Pain
D000072716	Cancer Pain
D059390	Breakthrough Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008691	Methadone

Ancestor Terms

ID	Term
D007659	Ketones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided