oxybutynin and Diabetic Neuropathies

oxybutynin has been researched along with Diabetic Neuropathies in 8 studies

oxybutynin: RN given refers to parent cpd
oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder.

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 (8)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12

Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). (NCT01533428)
Timeframe: Baseline to between Weeks 2 and 12

Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8

Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). (NCT01533428)
Timeframe: Baseline to between Weeks 2 to 8

"Change From Pre-application inPain Now Score"

"Change from pre-application inPain Now score was measured on a scale from 0-10 where 0 equates to No Pain and 10 to Pain as bad as you can imagine. Participants were asked to provide pain ratings relative only to the area of pain undergoing treatment." (NCT01533428)
Timeframe: Pre-application and 15 minutes and 60 minutes after patch removal

Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12

Change from Baseline in the European Quality Of Life (QOL) questionnaire in 5 dimensions (EQ-5D) with Visual Analog Scale (VAS) to Weeks 2, 8 and 12. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0-100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL). (NCT01533428)
Timeframe: Baseline to Weeks 2, 8 and 12

Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12

The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance. (NCT01533428)
Timeframe: Baseline to Weeks 2, 8 and 12

Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.

The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance. (NCT01533428)
Timeframe: Baseline to Weeks 2, 8 and 12

Number of Participants Who Used Rescue Pain Medication Days 1 Through 5

Summarized number of participants who used Rescue Pain Medications for Pain (NCT01533428)
Timeframe: Days 1 - 5

Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12

Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12 (NCT01533428)
Timeframe: Baseline to Week 12

Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2

Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2 (NCT01533428)
Timeframe: Baseline to Week 2

Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8

Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8 (NCT01533428)
Timeframe: Baseline to Week 8

Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12

"Percent change in average sleep interference was measured by Question 9F of the Brief Pain Inventory-Diabetic Neuropathy (BPI DN) and was used to assess pain and sleep interference index. Daily sleep interference rating scale consists of an 11-point numerical scale with which the patient describes how pain related to diabetes has interfered with their sleep during the past 24 hours. On a scale 0 identifies pain does not interfere with sleep and 10 identifies pain completely interferes with sleep. Average sleep interference score is assessed from baseline to Weeks 2-8 and Weeks 2-12." (NCT01533428)
Timeframe: Baseline, Weeks 2-8 and Weeks 2-12

Percentage of Participants With 30% Reduction in Average Daily Pain Score.

Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). (NCT01533428)
Timeframe: Baseline, Weeks 2-8 and Weeks 2-12

Percentage of Participants With 50% Reduction in Average Daily Pain Score.

Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). (NCT01533428)
Timeframe: Baseline, Weeks 2-8 and Weeks 2-12

Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12

Number of patients assessed for Safety through Adverse Events (AE) and Serious Adverse Events (SAE), vital signs, and laboratory analyses from baseline to week 12 (NCT01533428)
Timeframe: Baseline to Week 12

Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.

Tolerability of patch application was assessed by dermal assessment (0 to 7 point severity score on Dermal Assessment Scale). Data reported is based on the number of participants in the combined category with a score ≥ 4 (Definite edema or higher), 15 and 60 minutes after patch removal. (NCT01533428)
Timeframe: Day 1, 15 minutes and 60 minutes after patch removal

Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12

"Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question Over the past 7 days, how much has the study treatment improved your pain level?" (NCT01533428)
Timeframe: Baseline, Weeks 8 and 12

Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline

Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). (NCT01533428)
Timeframe: Baseline and Weeks 2, 4, 8 and 12

Weekly Percent Change From Baseline in Average Daily Pain Score

Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine). (NCT01533428)
Timeframe: Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12

Reviews

3 reviews available for oxybutynin and Diabetic Neuropathies

Trials

2 trials available for oxybutynin and Diabetic Neuropathies

Other Studies

3 other studies available for oxybutynin and Diabetic Neuropathies