Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT05259865 |
| Other study ID # |
2020-043 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 21, 2025 |
| Est. completion date |
December 31, 2027 |
Study information
| Verified date |
February 2024 |
| Source |
Canadian Forces Health Services Centre Ottawa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Understanding the impact of genetics could aid rational, precision drug choices. In the
current study, investigators will focus on whether genetic analysis of drug processing using
the Inagene platform could predict efficacy and side effect profile in patients prescribed
medication for pain.
Description:
Understanding the impact of genetics could aid rational, precision drug choices. In the
current study, investigators will focus on whether genetic analysis of drug processing using
the Inagene platform could predict efficacy and side effect profile in patients prescribed
medication for pain. In the investigator's clinic commonly employed medications included
nortriptyline, duloxetine, topiramate, gabapentin, pregabalin, opioids (morphine derivatives,
tramadol, tapentadol, buprenorphine patch), cesamet (a synthetic cannabinoid). To the
investigator's knowledge this type of study has not been completed in this environment and/or
patient population.
Research Objectives:
The main goal of this study is to determine whether genetic analysis of drug processing could
help predict efficacy and side effect profiles of medications in a cohort of patients
suffering from chronic pain.
In order to control for various clinical factors, patient reported outcomes will also be
collected. As a standard part of any patient intake, pain diagrams, measures of pain,
function, mental health status and exercise describe the conditions and relative impact will
be included. Investigators will include various standardized and/or adapted versions of other
questionnaires which will allow investigators to control for known confounders.
The following information will be collected at baseline
1. Demographics - age, gender, rank, working status, medical category
2. Patient Reported Outcomes at baseline (Appendix A)
1. Body Pain Diagram
2. Pain, Enjoyment and General Activity Scale (PEG)
3. Pain Disability Index
4. Hospital Anxiety and Depressions Scale (HADS)
5. Adapted Deployment Risk & Resilience Inventory 2 Section J: Unit Support Exercise
Questionnaire
6. Brief Trauma Questionnaire (BTQ)
7. Litigation Status
The following information will be collected at follow up, defined by discontinuation of
medication or continuation on medication associated with predefined measure of clinical
efficacy
1. Medication Efficacy and Side effect Form - for each prescribed medication noted
perceived efficacy, severity of side effects and general comments. This will be
completed at either the time of medication discontinuation, or when no further changes
to dosing is made.
2. Previous medication taken (Appendix B) - investigators will look specifically at
commonly prescribed pain medications, including: nortriptyline, duloxetine, topiramate,
gabapentin, pregabalin, opioids (ie morphine derivatives, tramadol, tapentadol,
buprenorphine patch), Cesamet and plant based cannabis. If necessary, the patient's
health record will be accessed to complete this record
3. Current medications
4. Smoking status and total starting/current dose
Clinical efficacy will be defined by achieving 5-8 on the Patient Global Impression of Change
scale (PGIC). Medication selection will be done in accordance with current standard of care,
patient informed consent and clinical experience. Prescription of medication will not be
directed by the results of the genetics analytics. Doses will be adjusted if side effects
permit and until clinical efficacy is achieved
Classification of inferred phenotypes (i.e. ultrarapid, normal, intermediate and poor
metabolizer) will be consistent with the recently published guidance for allele function
status. As noted, there are four possible scores for each tested medication, ranging from
1-4, which includes; 1) do not use 2) caution 3) use as directed 4) preferred. For the main
analysis, the phenotypes will be grouped 1&2 (do not prescribe) and 3&4 (prescribe) and
compared against whether patient responded or not to determine sensitivity and specificity of
the genetic testing. Sub-analysis will determine for those that did not respond and whether
this was a result of side effects or a lack of efficacy. From a functional standpoint for
each recommendation the pharmacogenetics testing will classified into green (prescribe),
yellow (caution), red (do no prescribe). All yellow outcomes will be reviewed to determine if
the clinical information (ie dosing, smoking, and/or current medications), could allow for
re-classification to a green or red recommendation for the purpose of the analysis.
The distribution of the prediction score will also be separately evaluated for medications
actively taken by participants and for medications that had been discontinued. The
distribution of prediction scores will be compared using ANOVA. Genetic prediction scores
will be separately compared against participants reported efficacy and side effects profile
using Spearman's correlation coefficient, and the respective p values will be calculated, and
corrected for multiple comparison
Patient Care:
Participation in the current study will not impact patient care or impact decision making
regarding medication. Each patient is simply evaluating the effects of the medications so
that we can compare their experiences with the predictive abilities of genetic prediction
score.
