Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy
NCT01770964
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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;
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy | |||
Official Title ICMJE | Evaluation of the Impact of Subject and Staff Training on the Pregabalin vs. Placebo Difference in Subjects With Painful Diabetic Neuropathy (PDN) | |||
Brief 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. 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE | 90 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | July 2013 | |||
Estimated Primary Completion Date | July 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01770964 | |||
Other Study ID Numbers ICMJE | ALPMF-0007-2012 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Analgesic Solutions | |||
Study Sponsor ICMJE | Analgesic Solutions | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Analgesic Solutions | |||
Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |