gabapentin and Diabetic Neuropathies

gabapentin has been researched along with Diabetic Neuropathies in 133 studies

Gabapentin: A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.
gabapentin : A gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome.

Diabetic Neuropathies: Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)

Research

Studies (133)

Authors

Clinical Trials (26)

Trial Overview

Trial Outcomes

Change From Baseline at Week 1 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.~Change from baseline: Score at Week 1 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 1

Change From Baseline at Week 10 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.~Change from baseline: Score at Week 10 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 10

Change From Baseline at Week 11 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.~Change from baseline: Score at Week 11 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 11

Change From Baseline at Week 12 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.~Change from baseline: Score at Week 12 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 12

Change From Baseline at Week 13 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.~Change from baseline: Score at Week 13 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 13

Change From Baseline at Week 2 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.~Change from baseline: Score at Week 2 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 2

Change From Baseline at Week 3 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.~Change from baseline: Score at Week 3 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 3

Change From Baseline at Week 4 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.~Change from baseline: Score at Week 4 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 4

Change From Baseline at Week 5 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.~Change from baseline: Score at Week 5 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 5

Change From Baseline at Week 6 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.~Change from baseline: Score at Week 6 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 6

Change From Baseline at Week 7 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.~Change from baseline: Score at Week 7 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 7

Change From Baseline at Week 8 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.~Change from baseline: Score at Week 8 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 8

Change From Baseline at Week 9 in Mean Weekly Pain Scores

"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.~Change from baseline: Score at Week 9 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 9

Change From Baseline in Mean Sleep Interference Scores

The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence

The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality

The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores

Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations

Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr). (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Clinical Global Impression of Change

Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00553475)
Timeframe: Week 13 or up to discontinuation

Number of Responders

A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Patient Global Impression of Change

The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00553475)
Timeframe: Week 13 or up to discontinuation

2) The Difference in Change Between Quantified Utah Early Neuropathy Examination Scores, Between Treatment and Placebo Groups Between Visits 1 and 8.

"The Utah Early Neuropathy Scale (UENS) was developed specifically to detect and quantify early small-fiber sensory neuropathy and to recognize modest changes in sensory severity and distribution.~The UENS scale ranges from 0 (no neuropathy) to 42 (severe small fiber neuropathy). The outcome measure is the UENS score from Visit 8 minus the UENS score at visit 1. The difference in the two scores indicates the change in neuropathy severity. A positive value indicates that neuropathy has worsened over the course of the study, a negative value indicates that neuropathy has improved over the course of the study." (NCT03401073)
Timeframe: Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays).

The Change in Nerve Fiber Density Between Visits 1 and 8.

"Difference in intra-epidermal nerve fiber density between visits 1 and 8 will be measured.~Intra-epidermal nerve fiber density is a quantitative measure of the number of nerve fibers per millimeter. The outcome is the number of nerve fibers measured at visit 8 minus the number of nerve fibers measured at visit 1. A positive value indicates that nerve fiber density has increased (a better outcome), a negative value indicates that the nerve fiber density has decreased (a worse outcome)." (NCT03401073)
Timeframe: Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays).

The Change in Neuropathic Pain Severity Between Visits 1 and 8.

"The visual analog scale (VAS) of pain allows for quantification of neuropathic pain.~The VAS pain scale depicts a line ranging from 0 (no pain) to 10 (worst possible pain). The scale is ordinal ranging from 0-10.~The difference in pain between visit 1 and visit 8 (pain measured at visit 8 subtracted from the score at visit 1) is the range. Positive values indicate an increase in pain (worse outcome), negative values indicate an improvement in pain (better outcome)." (NCT03401073)
Timeframe: Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays).

Number of Participants With Adverse Events (AEs)

An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. (NCT01364298)
Timeframe: Day 7 up to Day 84 (+7 days)

Profile of Mood States (POMS) Score

"POMS is a rating scale, which comprises of 65 items that are evaluated in a 0-4 scale, where 0 means not at all and 4 extremely. The scores for the 65 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score." (NCT01364298)
Timeframe: Day 84 (Week 12)

Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84

An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84. (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)

Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84

The LANSS scale score is 7-item pain scale that consists of grouped sensory description and sensory examination with simple scoring system. Evaluations in two main areas: pain and sensorial exploration. The first 5 questions asks for presence of unpleasant skin sensations (pricking, tingling, pins and needles), appearance of skin (mottled, red, or pink), increased sensitivity of skin to touch, sudden bursts of electric shock sensations, and hot or burning skin sensations. Last 2 questions involve sensory testing for the presence of allodynia and altered pinprick threshold. Different numbers of points, relative to their significance to neuropathic pain, are given to positive answers for maximum of 24 points. A score less than 12 makes unlikely that participant's symptoms are neuropathic in nature, whereas score more than 12 make neuropathic mechanisms likely to be contributing to participant's pain. Change from baseline data has been calculated as value at baseline minus value at Day 84. (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)

Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84

VAS is used to rate the pain as per 10 centimeter (cm) line. The pain intensity score ranges from '0=no pain' to '10=worst possible pain'. Change from baseline data has been calculated as value at baseline minus value at Day 84. (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)

Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale

CGIC is an assessment that the physician performs to assess the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse). (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)

Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale

GIPC is an assessment that the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse). (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)

Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)

NPIS is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)

Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration

Sleep evaluation was performed by assessing number of participants who fell asleep in a particular pre-specified range of time duration, that is, 0-15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes and greater than 60 minutes at Day 84 (Week 12). (NCT01364298)
Timeframe: Day 84 (Week 12)

Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score

A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Body Weight

Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks

Mean Change From Baseline to 12 Weeks in Heart Rate

Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks

Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks

This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline, 12 weeks

Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks

This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline, 12 weeks

Number of Participants With Treatment-Emergent Elevated Heart Rate

Elevated heart rate: >=100 beats per minute (bpm) + an increase of >=10 bpm if baseline <100 bpm. (NCT00385671)
Timeframe: baseline through 12 weeks

Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score

This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline, 12 weeks

Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00385671)
Timeframe: 12 weeks

Summary of Number of Participants Who Discontinued

Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow. (NCT00385671)
Timeframe: baseline through 12 weeks

Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score

This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline through 12 weeks

Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score

This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline through 12 weeks

Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores

The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score. (NCT00385671)
Timeframe: baseline, 12 weeks

Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale

The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care. (NCT00385671)
Timeframe: baseline, 12 weeks

Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores

14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score. (NCT00385671)
Timeframe: baseline, 12 weeks

Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure

Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs. (NCT00385671)
Timeframe: baseline through 12 weeks

Mean Change From Baseline to 12 Weeks in Blood Pressure

Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life

A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood

A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work

A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People

A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep

A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability

A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity

A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score

The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain

A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain

A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now

A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain

A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 Weeks

Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose

(NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Hemoglobin A1C

(NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels

Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)

The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores

The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores

14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3

The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Mean Change From Baseline to 12 Weeks in Total Bilirubin

(NCT00385671)
Timeframe: baseline, 12 weeks

Number of Participants With Treatment-Emergent Changes in Body Weight

"Treatment-emergent high body weight: weight at last visit >=107% of baseline weight.~Treatment-emergent low body weight: weight at last visit <=93% of baseline weight." (NCT00385671)
Timeframe: baseline through 12 weeks

Number of Participants With Treatment-emergent Elevated Blood Pressure

"Elevated systolic blood pressure: >=130 millimeter mercury (mm Hg) + an increase of >=10 mm Hg if baseline <130 mm Hg.~Elevated diastolic blood pressure: >=85 mm Hg + an increase of >=10 mm Hg if baseline <85 mm Hg." (NCT00385671)
Timeframe: baseline through 12 weeks

Number of Patients With Treatment-Emergent Elevated Laboratory Analytes

Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): >34, male (m): >36. Alanine Aminotransferase (ALT): f:<69 years (yr) >34, ≥69yr >32; m: <69yr >43, ≥69yr >35. Total Bilirubin (TBili): >21. Gamma Glutamyl Transferase (GGT): f: <59yr >49, ≥59yr >50; m: <59yr >61, ≥59yr >50. Fasting Plasma Glucose (FPG): <59yr >6.4, ≥59yr >6.7. Hemoglobin A1C (HbA1C) >6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr >106, 50-70yr >123, 70-80yr >164, ≥80yr >221; m: 18-50yr >129, 50-70yr >131, 70-80yr >156, ≥80yr >187 (NCT00385671)
Timeframe: baseline through 12 weeks

Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms

Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects. (NCT00385671)
Timeframe: baseline through 12 weeks

Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation

(NCT00385671)
Timeframe: baseline through 12 weeks

Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)

Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks

Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)

This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for <56 contiguous days prior to randomization. Prior use: use of gabapentin for >=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks

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