Acute PainNCT02599870
Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
A study testing NeuroIDgenetix Test Panel in people with Acute Pain and Surgery, run by AltheaDx at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment when implemented into the pre-operative process for patients undergoing an elective spinal surgical procedure and requiring post-operative acute pain management, as compared to a group of subjects with the same attributes… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Pain, Surgery
- What is being tested?
- NeuroIDgenetix Test Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects over the age of 18;
- Patients undergoing an elective spine surgical procedures
- Willing and able to comply with study procedures
- Able to provide written informed consent
- Surgery timing - scheduled to occur after PGx testing and IDgenetix test report review (at least 4 days after Pre-Op visit)
Who cannot join
- Unwilling or unable to provide written informed consent and to comply with study procedures
- Any subject for whom providing a buccal swab sample would be contraindicated or not possible
- Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5)
- abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis)
- a history of malabsorption (short gut syndrome)
- any gastric or small bowel surgery less than 3 months prior to study enrollment
- Patients with a significant unstable medical condition or life threatening disease
- History of prior pharmacogenetic testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Study to Evaluate the Clinical Impact of Pharmacogenetics-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment when implemented into the pre-operative process for patients undergoing an elective spinal surgical procedure and requiring post-operative acute pain management, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their post-surgery pain management. This study will also evaluate whether PGx testing can reduce narcotic consumption, opioid-related adverse effects, time to mobilization, medical visits and costs.
Read the detailed description
The incidence of opioid related adverse drug events can reach as high as 50% in surgical patients and poor pain management is a significant risk factor for early readmission. In addition, the rate of non- response to certain analgesics is double in patients who are poor metabolizers as demonstrated by mutations in both CPY26d alleles. Finally, there is a growing body of literature that ineffective acute pain management contributes significantly to the risk of chronic pain syndromes. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.
Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.
In this prospective, randomized, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on the duration of the post-surgical hospital stay and on patient well-being as determined by post-op pain assessments. Additionally, the impact of PGx-guided treatment on narcotic consumption, number of adverse events, re-admission rates and costs will be evaluated during the study duration.
- Conditions
- Acute Pain, Surgery
- Being tested
- NeuroIDgenetix Test Panel
- Keywords
- PGx, pharmacogenetic testing, IDgenetix, Pain Management, AltheaDx, Post-Operative Pain Management
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroIDgenetix Test PanelGenetic
Also called IDgenetix Neuro Test, PGx Testing
The NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient.
| Study group | Role | What they receive |
|---|---|---|
| NeuroIDgenetix Test Panel Intervention | Experimental | The medical provider for the NeuroIDgenetix-guided group will make post-operative pain management recommendations based on test results. Patient outcomes, length of hospital stay and number of medical visits will be measured throughout the study. Receives: Genetic: NeuroIDgenetix Test Panel |
| Control | No intervention | The medical provider for the control group will not receive the NeuroIDgenetix Test Panel results and will make post-operative pain management recommendations based as usual. Patient outcomes, length of hospital stay and number of medical visits will be measured throughout the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of length of post-surgical hospital stay between the two treatment arms.
Duration of the post-surgical hospital stay
Measured: From date of surgery until hospital discharge, assessed up to 3 months
Comparison of patient well being between the two treatment arms as measured by pain scores
Comparison of patient well being between the two treatment arms as measured by pain scores.
Measured: 3 months
Comparison of patient well being between the two treatment arms as measured by disability scores
Comparison of patient well being between the two treatment arms as measured by disability scores.
Measured: 3 months
Secondary outcomes (3)
Comparison of post-operative narcotic consumption between the two treatment arms
Comparison of post-operative narcotic consumption between the two treatment arms
Measured: 3 months
Comparison of opioid-related adverse effects between the two treatment arms
Comparison of opioid-related adverse effects between the two treatment arms
Measured: 3 months
Comparison of time to mobilization between the two treatment arms
Comparison of time to mobilization between the two treatment arms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- AltheaDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ochsner Health System
- Responsible party
- Sponsor
- Investigators
- Wale Sulaiman, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599870
- Sponsor's protocol ID
- CLP-0007
- Status last verified
- Jul 2018
- First submitted
- 23 Oct 2015
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Study to Evaluate the Clinical Impact of Pharmacogenetics-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
- ClinicalTrials.gov ID
- NCT02599870
- Acronym / sponsor ID
- CLP-0007
- Conditions
- Acute Pain, Surgery
- Keywords
- PGx, pharmacogenetic testing, IDgenetix, Pain Management, AltheaDx, Post-Operative Pain Management
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AltheaDxIndustry (pharma, biotech, devices)
- Collaborators
- Ochsner Health System
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment when implemented into the pre-operative process for patients undergoing an elective spinal surgical procedure and requiring post-operative acute pain management, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their post-surgery pain management. This study will also evaluate whether PGx testing can reduce narcotic consumption, opioid-related adverse effects, time to mobilization, medical visits and costs.
Detailed description
The incidence of opioid related adverse drug events can reach as high as 50% in surgical patients and poor pain management is a significant risk factor for early readmission. In addition, the rate of non- response to certain analgesics is double in patients who are poor metabolizers as demonstrated by mutations in both CPY26d alleles. Finally, there is a growing body of literature that ineffective acute pain management contributes significantly to the risk of chronic pain syndromes. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.
Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.
In this prospective, randomized, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on the duration of the post-surgical hospital stay and on patient well-being as determined by post-op pain assessments. Additionally, the impact of PGx-guided treatment on narcotic consumption, number of adverse events, re-admission rates and costs will be evaluated during the study duration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuroIDgenetix Test Panel Intervention | Experimental | Genetic: NeuroIDgenetix Test PanelThe medical provider for the NeuroIDgenetix-guided group will make post-operative pain management recommendations based on test results. Patient outcomes, length of hospital stay and number of medical visits will be measured throughout the study. |
| Control | No intervention | –The medical provider for the control group will not receive the NeuroIDgenetix Test Panel results and will make post-operative pain management recommendations based as usual. Patient outcomes, length of hospital stay and number of medical visits will be measured throughout the study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects over the age of 18;
- Patients undergoing an elective spine surgical procedures
- Willing and able to comply with study procedures
- Able to provide written informed consent
- Surgery timing - scheduled to occur after PGx testing and IDgenetix test report review (at least 4 days after Pre-Op visit)
Key exclusion criteria (8 listed)
- Unwilling or unable to provide written informed consent and to comply with study procedures
- Any subject for whom providing a buccal swab sample would be contraindicated or not possible
- Subject with a history of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5)
- abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase >1.5x normal, or suspected cirrhosis)
- a history of malabsorption (short gut syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroIDgenetix Test PanelAlso: IDgenetix Neuro Test, PGx TestingThe NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient. | Genetic | NeuroIDgenetix Test Panel Intervention |
Primary outcome
Comparison of length of post-surgical hospital stay between the two treatment arms.
Time frame: From date of surgery until hospital discharge, assessed up to 3 months
Duration of the post-surgical hospital stay
Comparison of patient well being between the two treatment arms as measured by pain scores
Time frame: 3 months
Comparison of patient well being between the two treatment arms as measured by pain scores.
Comparison of patient well being between the two treatment arms as measured by disability scores
Time frame: 3 months
Comparison of patient well being between the two treatment arms as measured by disability scores.
3 secondary outcomes
Comparison of post-operative narcotic consumption between the two treatment arms
Time frame: 3 months
Comparison of opioid-related adverse effects between the two treatment arms
Time frame: 3 months
Comparison of time to mobilization between the two treatment arms
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wale Sulaiman, MD principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroIDgenetix Test Panel in people with Acute Pain and Surgery, run by AltheaDx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of length of post-surgical hospital stay between the two treatment arms. (time frame: From date of surgery until hospital discharge, assessed up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.