Sublingual methadone for the management of cancer-related procedural pain in inpatients
| ISRCTN | ISRCTN72738824 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72738824 |
| ClinicalTrials.gov number | NCT00351637 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/04/2006
- Registration date
- 06/07/2006
- Last edited
- 31/01/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Neil Hagen
Scientific
Scientific
Room 374
Heritage Medical Research Building
3330 Hospital Dr. N.W.
Calgary
T2N 4N1
Canada
| Phone | +1 403 521 3446 |
|---|---|
| neilha@cancerboard.ab.ca |
Study information
| Study design | Open label multicentre prospective trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Sublingual methadone for the management of cancer-related procedural pain in inpatients: a phase II multicentre, open label, feasibility study |
| Study acronym | SLM INPT |
| Study objectives | The overall goal of this research is to evaluate the effectiveness of sublingual methadone for cancer-related breakthrough pain (onset to time of meaningful relief and the duration of the relief of breakthrough pain). The overall hypothesis is that sublingual methadone, once optimal dose has been reached, will pre-empt or relieve moderate to severe treatment-related, incident pain within five minutes in at least half of episodes evaluated. The purpose of this phase II study is to determine the feasibility of the dose titration and assessment protocol in the inpatient 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. |
| Ethics approval(s) | Conjoint Health Research Ethics Board, original approval dated 18th May 2006; amendment approval granted 24th August 2006 |
| Health condition(s) or problem(s) studied | Cancer-related breakthrough pain |
| Intervention | Sublingual methadone |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Methadone |
| Primary outcome measure | 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. Specific aspects of feasibility are: 1. To demonstrate the feasibility of recruitment to a study for incident pain in the inpatient setting 2. Feasibility of dose titration in the inpatient setting 3. Feasibility of filling out the pain assessments 4. Provide preliminary evidence of efficacy 5. To provide further information to document safety of the model |
| Secondary outcome measures | 1. To develop a model of pharmacokinetic (PK) or pharmacodynamic (PD) study of breakthrough pain 2. To develop a research tool, the Breakthrough Pain Assessment Tool (BPAT) 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 |
| Overall study start date | 01/06/2006 |
| Completion date | 31/12/2007 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Canada
Study participating centre
Room 374
Calgary
T2N 4N1
Canada
T2N 4N1
Canada
Sponsor information
Alberta Cancer Board (Canada)
Charity
Charity
1220 Standard Life Building
10405 Jasper Avenue
Calgary
T5J 3N4
Canada
| Phone | +1 403 521 3446 |
|---|---|
| neilha@cancerboard.ab.ca | |
| Website | http://www.cancerboard.ab.ca/ |
"ROR" |
https://ror.org/01k1b2g25 |
Funders
Funder type
Charity
Alberta Cancer Board (Canada) - Competition (ref: 4640)
No information available
Infrastructural support by Canadian Institutes of Health Research (CIHR) grant number: PET 69772 - we received funding for Difficult Pain Problems NET Grant. The monies received were to provide infrastructural support for research or network activities across Canada.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
31/01/2019: Clinicaltrials.gov states that this trial was terminated by January 2012 due to low accrual
