Painful Diabetic Neuropathy (PDN)Phase 4NCT02842554
Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies
A Phase 4 study testing EPT and C in people with Painful Diabetic Neuropathy (PDN), run by Analgesic Solutions at 1 site in United States.
Trial summary
The purpose of this study is to assess the ability of Evoked Pain Training (EPT) and Drug/ Placebo Administration (DPA) training to increase subjects' ability to discriminate between active and placebo treatments in a double-blind crossover trial of a known analgesic, measured by standardized effect size, relative to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy (PDN)
- What is being tested?
- EPT and C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Oct 2015
- Phase
- Phase 4
- 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
Who may be able to join
- A subject must meet all of the following criteria to be enrolled in the study:
- Be a man or a non-pregnant, non-lactating woman 18 years or older. Women of childbearing potential should be willing to use an acceptable birth control method (at the Investigator's discretion) during the study to avoid pregnancy.
- Have voluntarily provided written informed consent.
- Be able to speak, read, write, and understand English, understand the consent form, complete study-related procedures, and communicate with the study staff.
- Have a clinical diagnosis of Painful Diabetic Neuropathy (PDN) for at least 6 months.
- Clinical diagnosis may be verified by medical records or by clinical examination during the first visit combined with a medical history of appropriate symptoms for at least 6 months.
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- Have a pain intensity score averaging ≥4 on a 0-10 NRS for average daily recall over past 24 hours. (This applies at V1, V2, and V5.)
- Have an average daily pain intensity of at least 4 on the 0-10 NRS on at least 20 out of the past 30 days.
- Be, in the opinion of the Investigator, in sufficiently good health to participate in the study at screening, based upon the results of a medical history, physical examination and laboratory analysis.
- Prior to each Treatment Period, the participants must meet the following additional criteria for randomization: Have average pain intensity (24-hour recall) ≥4 on the 0-10 NRS.
Who cannot join
- A subject must be excluded if any of the following criteria are met:
- Are pregnant and/or lactating.
- Have been diagnosed as having any inflammatory arthritis, gout, pseudo-gout, Paget's disease, fibromyalgia or any chronic pain syndrome that in the Investigator's opinion would interfere with the assessment or self-evaluation of pain and other symptoms of PDN.
- Have evidence for multiple causes of pain in the neuropathic pain area, such as lumbar radiculopathy.
- Have received or used any of the excluded/prohibited treatments or drugs specified in the list of prohibited treatments (below) or are unable to agree to the list of treatments prohibited during the study.
- Have a history of congestive heart failure, unstable coronary artery disease, stroke, or uncontrolled hypertension.
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- Have a history of significant gastrointestinal disease, including active gastro-duodenal ulcerations, perforations, or bleeds.
- Have abnormal clinical laboratory test results or vital signs unless deemed not clinically significant by the investigator.
- Have regularly worn false fingernails within the past 6 months (more than 25% of the time)
- Are undergoing active treatment for cancer, are known to be infected by human immunodeficiency virus, or are being acutely and intensively immunosuppressed following transplantation.
- Have a history of alcohol or other substance abuse (not including nicotine or tobacco) within 5 years.
- Have a history of suicide attempt within the past 1 year or suicidal ideation within the past 1 month.
- Have a history of epilepsy or other seizure disorder.
- Have creatinine clearance below 60 mL/min as calculated by Cockroft-Gault equation for serum creatinine.
- Known to have a condition that in the Investigator's judgment precludes participation in the study.
- Have previously been admitted to this study.
- Are involved in a worker's compensation, disability claim, or litigation related to medical condition or treatment that is open or was settled within the past 12 months. (Whether litigation is related to medical condition or treatment may be decided at the Investigator's discretion. Claims settled >12 months previously are permitted.)
- Have a known failure to respond to pregabalin, gabapentin, or oxycodone due to either efficacy or tolerability in previous treatment at therapeutically appropriate doses.
- Are allergic to or have a hypersensitivity to pregabalin or oxycodone.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the ability of Evoked Pain Training (EPT) and Drug/ Placebo Administration (DPA) training to increase subjects' ability to discriminate between active and placebo treatments in a double-blind crossover trial of a known analgesic, measured by standardized effect size, relative to untrained control subjects.
- Conditions
- Painful Diabetic Neuropathy (PDN)
- Being tested
- EPT, Drug Placebo Administration, C
- Keywords
- PDN, Painful Diabetic Neuropathy, Diabetes
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPTOther
Drug Placebo AdministrationDrug
COther
Also called Control
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| DPA | Other | Drug Placebo Administration Receives: Drug: Drug Placebo Administration |
| C | Other | Control Receives: Other: C |
| EPT | Other | Evoked Pain Training Receives: Other: EPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment Training
To assess the ability of Evoked Pain Training (EPT) and Drug/ Placebo Administration (DPA) training to increase subjects' ability to discriminate between active and placebo treatments in a double-blind crossover trial of a known analgesic, measured by standardized effect size, relative to untrained control subjects
Measured: 1 year
Secondary outcomes (1)
Predicted Response to Training
To evaluate whether baseline characteristics of subjects predict response to training, measured by differences in psychophysical profile between baseline and end of study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startAug 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Neuropathy (PDN)Studies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Analgesic Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Responsible party
- Sponsor
- Investigators
- Stephen Wright, MD, Principal investigator, Analgesic Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842554
- Sponsor's protocol ID
- GRN.PC.002
- Status last verified
- Jul 2016
- First submitted
- 21 Aug 2013
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training "Pain Connoisseurs" for Efficient Analgesic Proof-of-Concept Studies
- ClinicalTrials.gov ID
- NCT02842554
- Acronym / sponsor ID
- GRN.PC.002
- Conditions
- Painful Diabetic Neuropathy (PDN)
- Keywords
- PDN, Painful Diabetic Neuropathy, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Analgesic SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Study start
- Aug 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Jul 2016 (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 assess the ability of Evoked Pain Training (EPT) and Drug/ Placebo Administration (DPA) training to increase subjects' ability to discriminate between active and placebo treatments in a double-blind crossover trial of a known analgesic, measured by standardized effect size, relative to untrained control subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DPA | Other | Drug: Drug Placebo AdministrationDrug Placebo Administration |
| C | Other | Other: CControl |
| EPT | Other | Other: EPTEvoked Pain Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be a man or a non-pregnant, non-lactating woman 18 years or older. Women of childbearing potential should be willing to use an acceptable birth control method (at the Investigator's discretion) during the study to avoid pregnancy.
- Have voluntarily provided written informed consent.
- Be able to speak, read, write, and understand English, understand the consent form, complete study-related procedures, and communicate with the study staff.
- Have a clinical diagnosis of Painful Diabetic Neuropathy (PDN) for at least 6 months.
- Have a pain intensity score averaging ≥4 on a 0-10 NRS for average daily recall over past 24 hours. (This applies at V1, V2, and V5.)
Key exclusion criteria (19 listed)
- Are pregnant and/or lactating.
- Have been diagnosed as having any inflammatory arthritis, gout, pseudo-gout, Paget's disease, fibromyalgia or any chronic pain syndrome that in the Investigator's opinion would interfere with the assessment or self-evaluation of pain and other symptoms of PDN.
- Have evidence for multiple causes of pain in the neuropathic pain area, such as lumbar radiculopathy.
- Have received or used any of the excluded/prohibited treatments or drugs specified in the list of prohibited treatments (below) or are unable to agree to the list of treatments prohibited during the study.
- Have a history of congestive heart failure, unstable coronary artery disease, stroke, or uncontrolled hypertension.
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 |
|---|---|---|
| EPT | Other | EPT |
| Drug Placebo Administration | Drug | DPA |
| CAlso: ControlNo Intervention | Other | C |
Primary outcome
Pain Assessment Training
Time frame: 1 year
To assess the ability of Evoked Pain Training (EPT) and Drug/ Placebo Administration (DPA) training to increase subjects' ability to discriminate between active and placebo treatments in a double-blind crossover trial of a known analgesic, measured by standardized effect size, relative to untrained control subjects
1 secondary outcome
Predicted Response to Training
Time frame: 1 year
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 25 Jul 2016.
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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.
Stephen Wright, MD principal investigator
Analgesic Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EPT and C in people with Painful Diabetic Neuropathy (PDN), run by Analgesic Solutions 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 10 inclusion and 19 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 25 Jul 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Assessment Training (time frame: 1 year). 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 25 Jul 2016.