Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Interventions
- Drug: placebo
- Registration Number
- NCT01455415
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
- Type 1 or 2 diabetes with painful neuropathy
- Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
- Meet pre-defined level of pain severity at entrance
- History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
- Participated in a previous or ongoing pregabalin clinical trial
- Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2: Placebo placebo - 1: Pregabalin pregabalin -
- Primary Outcome Measures
Name Time Method Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) Daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) Daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Four items measure pain (0: no pain; 10: worst pain possible) at its "worst, "least", "average", and "now" (current pain) on an 11-point scale. Scores range from 0 - 10 with higher scores indicating greater pain severity.
BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Seven sub-questions evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on an 11-point scale (0: does not interfere; 10: completely interferes). Scores range from 0 - 10 with higher scores indicating greater interference.
Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates "does not interfere with sleep" and 10 indicates "completely interferes (unable to sleep due to pain)". Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary.
Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) The Hospital Anxiety and Depression Scale (HADS) is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.
HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) HADS is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.
Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", the middle item, is scored as 0, "very good" as -1, "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", the middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The (sub)scales are calculated without weighting of any kind, and reported as the integer sum of listed questionnaire items (range: -4 - 136). The QOL-DN version that was administered in this study was modified with a 2-week recall period.
Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. Item 9 is scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). The symptoms domain score should be summed as follow: Σ (1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 32). The QOL-DN version that was administered in this study was modified with a 2-week recall period.
Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). Activities of the daily living domain score should be summed as follow: Σ (12, 22, 23, 25, 26). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: 0 - 20). The QOL-DN version that was administered in the study was modified with a 2-week recall period.
Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. With exception of questions 31 and 32, items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). In question 31, "good", middle item, is scored as 0, "very good" as -1 , "excellent" as -2, "fair" as 1, and "poor" as 2. In question 32, "about the same", middle item, is scored as 0, "somewhat better" as -1, "much better" as -2, "somewhat worse" as 1, and "much worse" as 2. Physical functioning / large fiber domain score should be summed as follow: Σ (8, 11, 13 - 15, 24, 27 - 35). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: -4 - 56). QOL-DN version that was administered in the study was modified with a 2-week recall period.
Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). The small fiber domain score should be summed as follow: Σ (10, 16, 17, 18). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of the listed questionnaire items (range: 0 - 16). The QOL-DN version that was administered in this study was modified with a 2-week recall period.
Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, "no problem" to "severe problem"). The autonomic domain score should be summed as follow: Σ (19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 12). The QOL-DN version that was administered in this study was modified with a 2-week recall period.
Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale (no problems, some/moderate problems, extreme problems) and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.
EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale \[1 = no problems, 2 = some/moderate problems, 3 = extreme problems\] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.
EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale \[1 = no problems, 2 = some/moderate problems, 3 = extreme problems\] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.
EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale \[1 = no problems, 2 = some/moderate problems, 3 = extreme problems\] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.
EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale \[1 = no problems, 2 = some/moderate problems, 3 = extreme problems\] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.
EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale \[1 = no problems, 2 = some/moderate problems, 3 = extreme problems\] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 - but later published in medical care in 2002.
EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period) End of Period (includes both Visits 5 and 9) EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale \[1 = no problems, 2 = some/moderate problems, 3 = extreme problems\] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 - but later published in medical care in 2002.
Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores End of Period 1 (V5) The PGIC is a participant-rated instrument that measures the participant's assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).
PGIC Score at the End of Period 1 (Week 6) - Categorized Scores End of Period 1 (V5) The PGIC is a participant-rated instrument that measures the participant's assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (7 different scores) and categorized scores (4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).
Trial Locations
- Locations (56)
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Coastal Connecticut Research, LLC
🇺🇸New London, Connecticut, United States
Dedicated Clinical Research
🇺🇸Goodyear, Arizona, United States
Neurological Group, PC
🇺🇸New London, Connecticut, United States
Davidson Medical Ministries
🇺🇸Lexington, North Carolina, United States
UNARS, s.r.o.
🇨🇿Pelhrimov, Czechia
Advanced Podiatry
🇺🇸Phoenix, Arizona, United States
The Office of Joshua D. Holland, M.D.
🇺🇸Phoenix, Arizona, United States
Clinical Research Consortium
🇺🇸Las Vegas, Nevada, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Genesis Clinical Research, LLC
🇺🇸Fall River, Massachusetts, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Houston Neurocare
🇺🇸Houston, Texas, United States
Fondazione PTV Policlinico Tor Vergata di Roma
🇮🇹Roma, Italy
Clintrial, s.r.o.
🇨🇿Praha 10, Czechia
Citydiabetes
🇸🇪Stockholm, Sweden
HealthCare Partners Medical Group
🇺🇸Los Angeles, California, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Sooner Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Arthritis and Diabetes Clinic, Inc.
🇺🇸Monroe, Louisiana, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Center for United Research, Inc.
🇺🇸Lakewood, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
IDS Pharmacy
🇺🇸Los Angeles, California, United States
Palm Beach Neurological Center,
🇺🇸Palm Beach Gardens, Florida, United States
Center for Lakemedelsstudier
🇸🇪Malmo, Sweden
V.Jerome Mirkil, MD
🇺🇸Las Vegas, Nevada, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Mercy Health Research
🇺🇸Saint Louis, Missouri, United States
Mirkil Medical Group
🇺🇸Las Vegas, Nevada, United States
Miray Medical Center
🇺🇸Brockton, Massachusetts, United States
The Office of Veronique Sebastian, MD
🇺🇸Oklahoma City, Oklahoma, United States
Blair Orthopedic Associates, Inc.
🇺🇸Altoona, Pennsylvania, United States
Neurology and Pain Clinic, LLC
🇺🇸Orangeburg, South Carolina, United States
New Phase Research and Development
🇺🇸Knoxville, Tennessee, United States
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
University of Southern California
🇺🇸Los Angeles, California, United States
Radiant Research (admin office)
🇺🇸Cincinnati, Ohio, United States
Sunstone Medical Research, LLC
🇺🇸Medford, Oregon, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
Borgess Diabetes Center
🇺🇸Kalamazoo, Michigan, United States
Centex Research, Inc.
🇺🇸Houston, Texas, United States
Suburban Clinical Research
🇺🇸Naperville, Illinois, United States
Columbus Research Foundation
🇺🇸Columbus, Georgia, United States
AGA Clinical Trials
🇺🇸Hialeah, Florida, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Clinical Research of Central Florida
🇺🇸Winter Haven, Florida, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Radiant Research
🇺🇸Columbus, Ohio, United States