Diabetes MellitusPhase 4NCT01770964
Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy
A Phase 4 study testing Pregabalin, Training Type A and Training Type B in people with Diabetes Mellitus and Painful Distal Symmetric Sensorimotor Polyneuropathy, run by Analgesic Solutions at 6 sites in United States.
Trial summary
The difference between active treatment and placebo in a clinical trial of an analgesic appears to depend on a variety of factors other than the actual efficacy of the drug itself, including various aspects of study design and conduct. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Painful Distal Symmetric Sensorimotor Polyneuropathy
- What is being tested?
- Pregabalin, Training Type A and Training Type B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2012to Jul 2013
- 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
- Willingly signs and dates an Informed Consent Form (ICF) that is approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), prior to the conduct of any study-specific procedures;
- Is at least 18 years old;
- Has a diagnosis of type 1 or type 2 diabetes and painful distal symmetric sensorimotor polyneuropathy;
- Has experienced a minimum duration of PDN of at least 6 months;
- Is on stable diabetic medication that is not expected to change during the study;
- Has a worst pain intensity over the past 24 hours as a 4 or higher on a 0-10 numerical rating scale at Screening;
- And is able to read and communicate meaningfully in English and comply with all study procedures
Who cannot join
- Has a psychiatric or psychological disorder that in the judgment of the Investigator would interfere with the completion of the study, confound the study results, or pose subject risk;
- Has an uncontrolled, clinically significant medical condition that in the judgment of the Investigator may contraindicate use of pregabalin or participation in the study (e.g., hepatic, respiratory, or hematologic illness; cardiovascular disease; or symptomatic peripheral vascular disease);
- Has experience as an investigator or a study staff member in clinical trials research in a role that involved direct patient contact;
- Participated in any of the following studies: Analgesic Solutions Protocol # ALPMF.SOW.0007, Analgesic Solutions Protocol # ALPMF.SOW.0007.02, or Astellas Protocol # E05-CL-3004;
- Has pain of other origin that might confound assessment of PDN;
- Has major skin ulceration;
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- Has had an amputation other than toes;
- Has a history of suicide attempt within the past 1 year;
- Reports current suicidal ideation within the past 1month;
- Has history of kidney disease that is likely to decrease creatinine clearance;
- Has creatinine clearance below 60 as calculated by Cockroft-Gault equation for serum creatinine;
- Has a history of drug or alcohol abuse within the past 1 year;
- Has hypersensitivity, intolerance, or allergy to pregabalin or gabapentin;
- Subject is pregnant, is considering becoming pregnant during the study, is breastfeeding or unwilling to use adequate birth control during the study;
- Participated in another clinical trial within the past month;
- Is involved in an ongoing or settled worker's compensation claim, disability, or litigation;
- Has a known failure to respond to pregabalin or gabapentin at a clinically relevant dose due to either efficacy or tolerability;
- Or has taken opioids on an as-needed basis within 1week of Screening, or has taken pregabalin or gabapentin within 30 days of screening. Subjects on stable doses opioids, antidepressants, non-steroidal anti-inflammatory drugs, or low-dose aspirin will be allowed to participate in the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Blair Medical Associates, Inc.
Altoona, Pennsylvania, 16602
Julia E Benton, RN, CCRC, 814-946-7569
Anthony J Bartkowiak, Jr., MD, FACP, CPI
- Recruiting
St. Elizabeth's Medica Center
Brighton, Massachusetts, 02135
Cameron Keith, BSN, RN, 617-789-2763
Frederic J Gerges, MD
- Recruiting
Neuro Care Medical Associates
Johnson City, New York, 13790
Kathe Rooney, 607-729-1521 ext. 308
Aamir Rasheed, MD
- Recruiting
Clinical Partners
Johnston, Rhode Island, 02919
Caroline DiGiulio, RN, 401-454-3800
Albert J Marano, MD
- Recruiting
University of Rochester
Rochester, New York, 14618
Maria Frazer, 585-340-8926
Armando A Villarreal, MD
- Recruiting
MedVadis Research Corporation
Watertown, Massachusetts, 02472
Alice Brown, MD, 617-744-1310
Alice Brown, MD
About this study
Official title: Evaluation of the Impact of Subject and Staff Training on the Pregabalin vs. Placebo Difference in Subjects With Painful Diabetic Neuropathy (PDN)
The difference between active treatment and placebo in a clinical trial of an analgesic appears to depend on a variety of factors other than the actual efficacy of the drug itself, including various aspects of study design and conduct. One potential such factor is how information about the study is presented to research staff and patients. The purpose of this study is to examine the impact of different presentations of information on the difference between pregabalin and placebo observed in a clinical trial in patients with painful diabetic neuropathy.
- Being tested
- Pregabalin, placebo, Training Type A, Training Type B
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
placeboDrug
Training Type ABehavioural
Training Type BBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Training Type A, pregabalin | Other | Subjects randomized to receive pregabalin at a site that received training Type A Receives: Drug: Pregabalin; Behavioral: Training Type A |
| Training Type B, pregabalin | Other | Subjects randomized to receive pregabalin at a site that received training Type B Receives: Drug: Pregabalin; Behavioral: Training Type B |
| Training Type A, placebo | Other | Subjects randomized to receive placebo at a site that received training Type A Receives: Drug: placebo; Behavioral: Training Type A |
| Training Type B, placebo | Other | Subjects randomized to receive placebo at a site that received training Type B Receives: Drug: placebo; Behavioral: Training Type B |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain severity rating
Measured: Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Analgesic Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V., Pfizer
- Responsible party
- Sponsor
- Investigators
- Jeremiah J Trudeau, PhD, Principal investigator, Analgesic Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770964
- Sponsor's protocol ID
- ALPMF-0007-2012
- Status last verified
- Jan 2013
- First submitted
- 13 Dec 2012
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Subject and Staff Training on the Pregabalin vs. Placebo Difference in Subjects With Painful Diabetic Neuropathy (PDN)
- ClinicalTrials.gov ID
- NCT01770964
- Acronym / sponsor ID
- ALPMF-0007-2012
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Analgesic SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Europe B.V., Pfizer
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 18 Jan 2013 (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 difference between active treatment and placebo in a clinical trial of an analgesic appears to depend on a variety of factors other than the actual efficacy of the drug itself, including various aspects of study design and conduct. One potential such factor is how information about the study is presented to research staff and patients. The purpose of this study is to examine the impact of different presentations of information on the difference between pregabalin and placebo observed in a clinical trial in patients with painful diabetic neuropathy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Training Type A, pregabalin | Other | Drug: Pregabalin, Behavioral: Training Type ASubjects randomized to receive pregabalin at a site that received training Type A |
| Training Type B, pregabalin | Other | Drug: Pregabalin, Behavioral: Training Type BSubjects randomized to receive pregabalin at a site that received training Type B |
| Training Type A, placebo | Other | Drug: placebo, Behavioral: Training Type ASubjects randomized to receive placebo at a site that received training Type A |
| Training Type B, placebo | Other | Drug: placebo, Behavioral: Training Type BSubjects randomized to receive placebo at a site that received training Type B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willingly signs and dates an Informed Consent Form (ICF) that is approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), prior to the conduct of any study-specific procedures;
- Is at least 18 years old;
- Has a diagnosis of type 1 or type 2 diabetes and painful distal symmetric sensorimotor polyneuropathy;
- Has experienced a minimum duration of PDN of at least 6 months;
- Is on stable diabetic medication that is not expected to change during the study;
Key exclusion criteria (18 listed)
- Has a psychiatric or psychological disorder that in the judgment of the Investigator would interfere with the completion of the study, confound the study results, or pose subject risk;
- Has an uncontrolled, clinically significant medical condition that in the judgment of the Investigator may contraindicate use of pregabalin or participation in the study (e.g., hepatic, respiratory, or hematologic illness; cardiovascular disease; or symptomatic peripheral vascular disease);
- Has experience as an investigator or a study staff member in clinical trials research in a role that involved direct patient contact;
- Participated in any of the following studies: Analgesic Solutions Protocol # ALPMF.SOW.0007, Analgesic Solutions Protocol # ALPMF.SOW.0007.02, or Astellas Protocol # E05-CL-3004;
- Has pain of other origin that might confound assessment of PDN;
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 |
|---|---|---|
| Pregabalin | Drug | Training Type A, pregabalin, Training Type B, pregabalin |
| placebo | Drug | Training Type A, placebo, Training Type B, placebo |
| Training Type A | Behavioural | Training Type A, placebo, Training Type A, pregabalin |
| Training Type B | Behavioural | Training Type B, placebo, Training Type B, pregabalin |
Primary outcome
change in pain severity rating
Time frame: Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
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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.
Jeremiah J Trudeau, PhD principal investigator
Analgesic Solutions
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin, Training Type A and Training Type B in people with Diabetes Mellitus and Painful Distal Symmetric Sensorimotor Polyneuropathy, run by Analgesic Solutions at 6 sites 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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain severity rating (time frame: Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18)). 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 18 Jan 2013.