Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neurop… (NCT01770964) | Clinical Trial Compass
UnknownPhase 4
Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy
United States90 participantsStarted 2012-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.00…
What they're measuring
1
change in pain severity rating
Timeframe: Screening/Visit 1 (Day 1) and Visit 4 (Day 15-18)