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Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

Primary Purpose

Diabetic Peripheral Neuropathy

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pregabalin

placebo

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring Diabetic Peripheral Neuropathy, Pain on Walking, Pregabalin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men or women who are at least 18 years old.
Diagnosis of painful diabetic peripheral neuropathy.
Pain on walking.

Exclusion Criteria:

Inability to walk 50 feet on a flat surface.
Pain on walking due to conditions other than diabetic peripheral neuropathy.

Sites / Locations

Dedicated Clinical Research
Arizona Research Center
Neuro-Pain Medical Center
HealthCare Partners Medical Group
IDS Pharmacy
University of Southern California
PAB Clinical Research
Pulmonary Associates of Brandon
Innovative Research of West Florida, Inc.
The Office of Laszlo Jozef Mate, MD
Meridien Research
Metabolic Research Institute, Inc.
Clinical Research of Central Florida
Columbus Research Foundation
MediSphere Medical Research Center, LLC
Heartland Research Associates, LLC
Quality Clinical Research, Inc.
Desert Endocrinology Clinical Research Center
Clinical Research Consortium
The Office of Dr. Stephen H. Miller, MD
The Medical Research Network, LLC
Neurology and Neuroscience Center of Ohio
Sooner Clinical Research
The Office of Veronique Sebastian, MD
Sunstone Medical Research, LLC
Oregon Health and Science University - Comprehensive Pain Center
Oregon Health and Science University - Department of Anesthesiology and Perioperative Medicine
Blair Orthopedic Associates, Inc.
Altoona Center for Clinical Research
Memorial Hospital of Rhode Island
Neurology and Pain Clinic, LLC
Houston Neurocare
Centex Research, Inc.
Eastern Virginia Medical School
Privatni specializovana ambulance pro neurologii a detskou neurologii
Clintrial, s.r.o.
Fakultni nemocnice v Motole
Dr DR Lakha's Practice
Dr Hemant Makan (Private Practice)
Randles Road Medical Centre
Richards Bay Trial Centre
Forskningsmottagningen Gamla Sjukhuset i Falkoping
Center for Lakemedelsstudier
Citydiabetes
Bragee Medect AB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pregabain

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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)

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 each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication 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.

DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)

The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of 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

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)

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 each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication 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)

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 each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication 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)

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. The BPI-sf consists of 5 questions: 4 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 - 40 with higher scores indicating greater pain severity. Another item, containing 7 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 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference.

BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)

BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)

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. The BPI-sf consists of 5 questions: 4 items measure pain on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 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 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. The sub-score pain interference with walking ability was evaluated, as it was considered to be the most relevant in the context of this study.

Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)

Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the "day" (non-sleep period). Actigraphy was performed with an accelerometer that was worn on the hip during the waking hours. It was programmed to record movements while the device was being worn.

Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)

Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. The participants were instructed to wear the device on their hip during the waking hours.

Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

The Walk-12 is a self-administered questionnaire that assesses the impact of the participant's diabetic neuropathy over the past 2 weeks on parameters associated with walking (12 questions) based on a 5-point scale (from not at all to extremely). The total score is the sum of scores from the 12 questions, which then gets transferred to a 0-100 scale with higher scores indicating greater impairment

Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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 scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.

Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. 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.

Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. The activities of daily living domain score should be summed as follow: Σ(12, 22, 23, 25, 26). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.

Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. The physical functioning / large fiber domain score should be summed as follow: Σ(8, 11, 13 - 15, 24, 27 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.

Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. The small fiber domain score should be summed as follow: Σ(10, 16, 17, 18). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.

Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. 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.

Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)

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 (OS; 7 different scores) and categorized scores (CS; 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 (V6).

Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

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)

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.

Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

The 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.

Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)

The EQ-5D describes participant's health status based on 5 attributes producing an 5 digit index score. The 5 dimensions are: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Dolan 1997 advised how to transfer this index score to a single score for clinical trials, a revised single index was published in 2001. The index uses general population weighted estimates for various health states. In general, the range of the single index tends to vary between 0 = death and 1 = perfect health and there are some states that have been rated by the general population to be worse than death which may result in numbers below 0.

Full Information

NCT ID

NCT01474772

First Posted

November 15, 2011

Last Updated

January 26, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01474772

Brief Title

Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

Official Title

A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy, Pain on Walking, Pregabalin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

217 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pregabain

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

150-300 mg/day given in 3 divided doses as capsules

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

matching placebo capsules given in 3 divided doses

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Secondary Outcome Measure Information:

Title

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)

Description

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 each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication 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.

Time Frame

End of Period (includes both Visits 6 and 11)

Title

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)

Description

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 each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication 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.

Time Frame

End of Period (includes both Visits 6 and 11)

Title

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)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Description

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. The BPI-sf consists of 5 questions: 4 items measure pain on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 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 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. The sub-score pain interference with walking ability was evaluated, as it was considered to be the most relevant in the context of this study.

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. 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.

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. The activities of daily living domain score should be summed as follow: Σ(12, 22, 23, 25, 26). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. The physical functioning / large fiber domain score should be summed as follow: Σ(8, 11, 13 - 15, 24, 27 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. The small fiber domain score should be summed as follow: Σ(10, 16, 17, 18). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items.

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the 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 the 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. 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.

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)

Description

Time Frame

End of Period 1 (V6)

Title

Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

Title

Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)

Description

Time Frame

End of Period (includes both Visits 6 and 11)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men or women who are at least 18 years old. Diagnosis of painful diabetic peripheral neuropathy. Pain on walking. Exclusion Criteria: Inability to walk 50 feet on a flat surface. Pain on walking due to conditions other than diabetic peripheral neuropathy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Dedicated Clinical Research

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85395

Country

United States

Facility Name

Arizona Research Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Neuro-Pain Medical Center

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

HealthCare Partners Medical Group

City

Los Angeles

State/Province

California

ZIP/Postal Code

90015

Country

United States

Facility Name

IDS Pharmacy

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

PAB Clinical Research

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Pulmonary Associates of Brandon

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Innovative Research of West Florida, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

The Office of Laszlo Jozef Mate, MD

City

North Palm Beach

State/Province

Florida

ZIP/Postal Code

33408

Country

United States

Facility Name

Meridien Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Metabolic Research Institute, Inc.

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Clinical Research of Central Florida

City

Winter Haven

State/Province

Florida

ZIP/Postal Code

33880

Country

United States

Facility Name

Columbus Research Foundation

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

MediSphere Medical Research Center, LLC

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Heartland Research Associates, LLC

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

Quality Clinical Research, Inc.

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Desert Endocrinology Clinical Research Center

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Clinical Research Consortium

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

The Office of Dr. Stephen H. Miller, MD

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89144

Country

United States

Facility Name

The Medical Research Network, LLC

City

New York

State/Province

New York

ZIP/Postal Code

10128

Country

United States

Facility Name

Neurology and Neuroscience Center of Ohio

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

Sooner Clinical Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

The Office of Veronique Sebastian, MD

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Sunstone Medical Research, LLC

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Oregon Health and Science University - Comprehensive Pain Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Oregon Health and Science University - Department of Anesthesiology and Perioperative Medicine

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Blair Orthopedic Associates, Inc.

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Memorial Hospital of Rhode Island

City

Pawtucket

State/Province

Rhode Island

ZIP/Postal Code

02860

Country

United States

Facility Name

Neurology and Pain Clinic, LLC

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Houston Neurocare

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Centex Research, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77062

Country

United States

Facility Name

Eastern Virginia Medical School

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Privatni specializovana ambulance pro neurologii a detskou neurologii

City

Brno-Bystrc

ZIP/Postal Code

635 00

Country

Czechia

Facility Name

Clintrial, s.r.o.

City

Praha 10

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

Fakultni nemocnice v Motole

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Dr DR Lakha's Practice

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

1829

Country

South Africa

Facility Name

Dr Hemant Makan (Private Practice)

City

Lenasia

State/Province

Gauteng

ZIP/Postal Code

1820

Country

South Africa

Facility Name

Randles Road Medical Centre

City

Durban

State/Province

Kwa-Zulu Natal

ZIP/Postal Code

4000

Country

South Africa

Facility Name

Richards Bay Trial Centre

City

Richards Bay

ZIP/Postal Code

3900

Country

South Africa

Facility Name

Forskningsmottagningen Gamla Sjukhuset i Falkoping

City

Falkoping

ZIP/Postal Code

521 43

Country

Sweden

Facility Name

Center for Lakemedelsstudier

City

Malmo

ZIP/Postal Code

211 52

Country

Sweden

Facility Name

Citydiabetes

City

Stockholm

ZIP/Postal Code

111 57

Country

Sweden

Facility Name

Bragee Medect AB

City

Stockholm

ZIP/Postal Code

115 22

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

25565583

Citation

Huffman C, Stacey BR, Tuchman M, Burbridge C, Li C, Parsons B, Pauer L, Scavone JM, Behar R, Yurkewicz L. Efficacy and Safety of Pregabalin in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy and Pain on Walking. Clin J Pain. 2015 Nov;31(11):946-58. doi: 10.1097/AJP.0000000000000198.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081269&StudyName=Efficacy%20and%20Safety%20Study%20of%20Pregabalin%20in%20the%20Treatment%20of%20Pain%20on%20Walking%20in%20Patients%20with%20Diabetic%20Peripheral%20Neuropathy%20%28DPN%29

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)

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