Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP
- Conditions
- Diabetic Peripheral Neuropathic Pain (DPN)Postherpetic Neuralgia (PHN)HIV-related Neuropathic Pain (HIV)Chemotherapy Induced Neuropathic Pain
- Interventions
- Registration Number
- NCT00407511
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
- Patients who are diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
- Severe Pain associated with conditions other than Diabetic Peripheral Neuropathy, Post-Herpetic Neuralgia, Human Immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy that may confound assessment or self evaluation of the neuropathic pain.
- Skin Condition in the affected dermatome that (in the judgment of the investigator) could alter sensation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pregabalin Pregabalin -
- Primary Outcome Measures
Name Time Method Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) Baseline, End of Treatment 11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF 100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) Week 4, Week 8, Week 12 11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.
Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF) Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication Baseline, Week 8, Week 12, EOT/LOCF Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4.
Clinical Global Impression of Change (CGIC) End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) 7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).
Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores Baseline, Week 8, Week 12, EOT/LOCF Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication Baseline, Week 8, Week 12, EOT/LOCF Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4.
Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) Baseline, Week 8, Week 12, EOT/LOCF 100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.
Patient Global Impression of Change (PGIC) End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) 7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)
Change From Baseline in Mean Daily Sleep Interference Score (DSIS) Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇻🇪Caracas, Distrito Capital, Venezuela