QSPainRelief-STRAT (QSPR-STRAT)

January 29, 2024 updated by: Université Catholique de Louvain

QSPainRelief-STRAT: A Questionnaire-based Evaluation of Perceived Clinical Outcome in Patients With Persistent Pain Receiving an Opioid and Non-opioid Treatment Combination, Stratified According to Age and Sex

Investigating the clinical outcomes of drug combinations (opioid + medication acting on the central nervous system) in patients suffering from persistent pain (pain lasting for at least three months) through patient-reported outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is part of the QSPainRelief project funded by the European Union's Horizon 2020 research and innovation program (grant agreement 848068; http://qspainrelief.eu).

The QSPainRelief project aims to setup, calibrate and validate a platform to predict the effects of treatment combinations according to patient characteristics such as age and sex (QSPainRelief platform) which integrates recently developed (1) physiologically based pharmacokinetic models to quantitate and adequately predict drug pharmacokinetics in human CNS, (2) target-binding kinetic models; (3) cellular signaling models and (4) a proprietary neural circuit model to quantitate the drug effects on the activity of relevant brain neuronal networks, that also adequately predicts clinical outcome.

To develop the QSPainrelief platform, a large dataset assessing perceived clinical outcome by real-world patients treated with a drug combination and stratified according to age and sex is required. To generate this dataset, we will conduct a questionnaire-based clinical study using an online platform (Redcap) and/or phone interviews to assess baseline patient characteristics and clinical outcome. Eligible patients are any patient treated with an opioid analgesic to whom an add-on treatment acting on the CNS is prescribed.

This study will focus on pain relief and its impact on daily life activities as therapeutic effects, and on drug-induced sedation, drug-induced cognitive dysfunction (memory and attention) and pain medication misuse as adverse effects. These adverse effects have been chosen because they can be readily assessed in patients after a short treatment period using validated patient-reported outcome measures (PROMs).

QSPainRelief-patientSTRAT is a monocentric prospective longitudinal questionnaire-based study conducted in patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged over 18 years.
  2. Current treatment with an opioid for the treatment of pain, along with possible other drugs (see Table 1 for the list of eligible opioid medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
  3. Decision by the treating physician to introduce an additional non-opioid CNS-acting treatment such as an antiepileptic, an anti-depressant or benzodiazepine (see Table 2 for the list of eligible medications - patients will be invited to indicate their treatment by selecting its name using a dropdown list).
  4. Capacity to understand and provide informed consent.

Exclusion Criteria:

  1. Insufficient French language skills.
  2. Epilepsy treated by an anti-epileptic.
  3. Alzheimer's disease.
  4. Parkinson's disease
  5. History of cancer diagnosed less than 5 years ago, treated by chemotherapy or radiotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Peristent Pain Patients

Patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment), will be included.

Evaluation of drug combination pain relief and its impact on daily life activities as therapeutic effects, and on drug-induced sedation and drug-induced cognitive dysfunction (memory and attention) as adverse effects will be evaluated through online (REDCap) patient-reported outcomes at the beginning of the study (day 0), 10 days and 3 months.
Combination product: Opioid drug + CNS-acting add-on drug
Patients suffering from persistent pain (pain lasting for at least three months), already treated with an opioid medication (treatment A) and to whom the treating physician is about to prescribe a CNS-acting add-on drug such as an antiepileptic, an antidepressant, a benzodiazepine or an alpha2-agonist (treatment B: the combination treatment).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 10 days and 3 months
The intensity of pain at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences pain relief, expressed as change in pain severity score from Day 0 to Day 10 and Month 3 realized with the Brief Pain Inventory (SF-BPI) pain severity score.
10 days and 3 months
Daily Life Activities
Time Frame: 10 days and 3 months
The impact on daily life activities at 10 days and 3 months post-drug combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences daily activities, expressed as change in daily life activities score from Day 0 to Day 10, and Month 3, realized with the Brief Pain Inventory (SF-BPI) daily life activities score.
10 days and 3 months
Quality of Life (EURO-QoL)
Time Frame: 3 months
The impact on quality of life at 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences quality of life, expressed as change in EuroQOL-5D score from Day 0 to Month 3.
3 months
Drug-induced sedation
Time Frame: 10 days and 3 months
Drug-induced sedation at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences sleepiness, expressed as change in the Stanford Sleepiness Scale score from Day 0 to Day 10 and Month 3
10 days and 3 months
Drug-induced cognitive dysfunction
Time Frame: 10 days and 3 months
. Drug-induced cognitive dysfunction (memory and attention) at 10 days and 3 months post-drug-combination compared vs. pre-drug combination. Assessment on how the combinational treatment influences cognitive functions, expressed as change in the PROMIS Neuro-QOL Short Form Cognitive Function score from Day 0 to Day 10 and Month 3.
10 days and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université Catholique de Louvain

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/13/JUI/259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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