Neuralgia PeripheralDExPriNCT04184596
Preferences in Pain Treatment: A Discrete Choice Experiment in Patients With Peripheral Neuropathic Pain (pNP)
An observational study of Neuralgia Peripheral and Neuropathic Pain, run by LinkCare GmbH at 3 sites in Germany.
Trial summary
The objective of this study is to identify and weight attributes of topic and systemic pain treatment options relevant from the patients' perspective with peripheral neuropathic pain. The study will use a discrete choice experimental design to reach its objective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia Peripheral, Neuropathic Pain, Patient Preference
- What is being tested?
- Discrete Choice Experiment
- How many people
- 153 participants
- Where
- 3 sitesGermany
- Study dates
- 11 Feb 2020to 31 Aug 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 150 patients will be included in this study. Participating centers are outpatient centers, specialist in pain treatment in the state of Hesse.
Who may be able to join
- Patients with diagnosed peripheral neuropathic pain (pNP) as assessed by study sites
Who cannot join
- Patients with no sufficient knowledge in written or oral German as assessed by study sites
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
LinkCare GmbH
Stuttgart, Baden-Wurttemberg, 70469
Schmerz- und Palliativzentrum Rhein-Main
Wiesbaden, Hesse, 65189
Schmerzpraxis Wiesbaden
Wiesbaden, Hesse, 65193
About this study
The objective of this study is to identify and weight attributes of topic and systemic pain treatment options relevant from the patients' perspective with peripheral neuropathic pain. The study will use a discrete choice experimental design to reach its objective.
- Conditions
- Neuralgia Peripheral, Neuropathic Pain, Patient Preference
- Being tested
- Discrete Choice Experiment
- Keywords
- Discrete Choice Experiment
- Medical subject headings
- Neuralgia, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discrete Choice ExperimentOther
An online-based Discrete-Choice Experiment (DCE) using a survey for stated treatment preferences and socio-demographics. Furthermore, the neuropathic pain component will be assessed in all patients with the Numeric Pain Rating Scale instrument.
| Study group | Role | What they receive |
|---|---|---|
| Stated-Preferences Observational Group | A discrete choice experiment will be conducted with participants with peripheral neuropathic pain in the stated-preferences observational group. The instrument will measure patient preferences for topical versus systemic pain treatment. Receives: Other: Discrete Choice Experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preferences for topical and systemic pain treatment attributes
Utility values obtained via multinominal logit estimates from discrete choice experiment
Measured: 20 minutes after survey start
Secondary outcomes (2)
Relevance of attributes attributed with topical and systemic pain treatment
Derived from Likert scale
Measured: 5 minutes after survey start
Marginal rate of substitution against pain reduction
Derived from discrete choice experiment
Measured: 20 minutes after survey start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start11 Feb 2020
- Primary completion30 Jul 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuralgia PeripheralStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- LinkCare GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Schmerzpraxis Wiesbaden, Schmerz- und Palliativzentrum Rhein-Main Wiesbaden, Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- Tino Schubert, MSc, Study chair, LinkCare GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184596
- Sponsor's protocol ID
- VF/1014/1070
- Acronym
- DExPri
- Status last verified
- Feb 2021
- First submitted
- 29 Nov 2019
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schubert T, Kern KU, Schneider S, Baron R. Oral or Topical Pain Therapy-How Would Patients Decide? A Discrete Choice Experiment in Patients with Peripheral Neuropathic Pain. Pain Pract. 2021 Jun;21(5):536-546. doi: 10.1111/papr.12989. Epub 2021 Feb 1.
PubMed 33342078
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preferences in Pain Treatment: A Discrete Choice Experiment in Patients With Peripheral Neuropathic Pain (pNP)
- ClinicalTrials.gov ID
- NCT04184596
- Acronym / sponsor ID
- DExPri / VF/1014/1070
- Conditions
- Neuralgia Peripheral, Neuropathic Pain, Patient Preference
- Keywords
- Discrete Choice Experiment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- LinkCare GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Schmerzpraxis Wiesbaden, Schmerz- und Palliativzentrum Rhein-Main Wiesbaden, Grünenthal GmbH
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 3 Dec 2019 (actual)
- 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 objective of this study is to identify and weight attributes of topic and systemic pain treatment options relevant from the patients' perspective with peripheral neuropathic pain. The study will use a discrete choice experimental design to reach its objective.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stated-Preferences Observational Group | – | Other: Discrete Choice ExperimentA discrete choice experiment will be conducted with participants with peripheral neuropathic pain in the stated-preferences observational group. The instrument will measure patient preferences for topical versus systemic pain treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 150 patients will be included in this study. Participating centers are outpatient centers, specialist in pain treatment in the state of Hesse.
Key inclusion criteria (1 listed)
- Patients with diagnosed peripheral neuropathic pain (pNP) as assessed by study sites
Key exclusion criteria (1 listed)
- Patients with no sufficient knowledge in written or oral German as assessed by study sites
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 |
|---|---|---|
| Discrete Choice ExperimentAn online-based Discrete-Choice Experiment (DCE) using a survey for stated treatment preferences and socio-demographics. Furthermore, the neuropathic pain component will be assessed in all patients with the Numeric Pain Rating Scale instrument. | Other | Stated-Preferences Observational Group |
Primary outcome
Patient preferences for topical and systemic pain treatment attributes
Time frame: 20 minutes after survey start
Utility values obtained via multinominal logit estimates from discrete choice experiment
2 secondary outcomes
Relevance of attributes attributed with topical and systemic pain treatment
Time frame: 5 minutes after survey start
Marginal rate of substitution against pain reduction
Time frame: 20 minutes after survey start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 33342078Schubert T, Kern KU, Schneider S, Baron R. Oral or Topical Pain Therapy-How Would Patients Decide? A Discrete Choice Experiment in Patients with Peripheral Neuropathic Pain. Pain Pract. 2021 Jun;21(5):536-546. doi: 10.1111/papr.12989. Epub 2021 Feb 1.
- Individual participant dataSharing planned: No
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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.
Tino Schubert, MSc study chair
LinkCare GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuralgia Peripheral and Neuropathic Pain, run by LinkCare GmbH at 3 sites in Germany.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient preferences for topical and systemic pain treatment attributes (time frame: 20 minutes after survey start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04184596, which also lists 1 linked publication.
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 21 Feb 2021.