A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Diabetic Peripheral Neuropathic Pain.
ETX-018810 is a new chemical entity that is under development as a non-opioid treatment for chronic pain syndromes. ETX-018810 is a prodrug of palmitoylethanolamide (PEA), an endogenous bioactive lipid that has shown efficacy in a broad range of nonclinical inflammatory and neuropathic pain models and in clinical trials in chronic pain indications, including diabetic peripheral neuropathic pain (DPNP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
167
Study Drug
Matching Placebo
Delta Clinical Research
Mobile, Alabama, United States
Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale (PI-NRS)
Change from baseline in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS) a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).
Time frame: baseline to Week 4
Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score
Change in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS) a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).
Time frame: Baseline to Weeks 1, 2, 3 and 4
Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score
Change in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS) a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).
Time frame: Baseline to Weeks 1, 2, 3 and 4
Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3
Change in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS) a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).
Time frame: Baseline to Weeks 1, 2 and 3
Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4
The Clinical Global Impression - Change (CGI-C) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The rater selects one response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are as follows: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.
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Arizona Research Center
Phoenix, Arizona, United States
Neuro-Pain Medical Cneter
Fresno, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Diabetes Research Center
Tustin, California, United States
Chase Medical Research LLC
Hamden, Connecticut, United States
Charter Research
Lady Lake, Florida, United States
Cordova Research Institute
Miami, Florida, United States
Coral Research Clinic Corp
Miami, Florida, United States
Better Health Clinical Reseach
Newnan, Georgia, United States
...and 12 more locations
Time frame: Week 4
Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4.
The Patient Global Impression - Change (PGI-C) is the patient-reported counterpoint to the CGI C (Guy, 1976). The qualitative assessment of meaningful change is determined by the patient in response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" Scores are as follows: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.
Time frame: Week 4
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4
The Daily Sleep Interference Scale (DSIS) is an 11-point response scale that quantifies sleep interference due to pain. It is a single-item measure that is completed once daily, upon awakening, to accurately capture variability in sleep interference due to pain on a daily basis, thus minimizing recall bias. Patients are asked to select the number that best describes how much their pain has interfered with their sleep during the last 24 hours on a scale from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep).
Time frame: Baseline to Weeks 1, 2, 3 and 4
Change in the BPI - Interference Scale From Baseline to Week 4
The BPI Interference scale measures how much pain has interfered with seven daily activities scored on a scale from 0 (does not interfere) to 10 (completely interferes). It is scored as the mean of the seven interference items.
Time frame: Baseline to Week 4
Change in the BPI-Pain Scale From Baseline to Week 4
The BPI pain scale is a composite of 4 items assessing pain severity (worst, least, average, and right now). Subjects rate their pain in last 24 hours on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). It is scored as the mean of the four pain items.
Time frame: Baseline to Week 4
Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4
The daily amount of acetaminophen (rescue medication) that was used (mg per day).
Time frame: Baseline to week 4