Phase 4
N=121
Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP
Diabetic Peripheral Neuropathic Pain (DPN) · Postherpetic Neuralgia (PHN) · HIV-related Neuropathic Pain (HIV) · Chemotherapy Induced Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00407511 ↗Enrolled (actual)
121
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) — -3.8 scores on scale — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pregabalin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) |
-3.8 | < 0.0001 sig |
| SECONDARY Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) |
-3.2; -3.9; -4.2 | < 0.0001 sig |
| SECONDARY Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores |
-4.2; -4.7; -4.6 | < 0.0001 sig |
| SECONDARY Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores |
-3.8; -4.2; -4.0 | < 0.0001 sig |
| SECONDARY Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication |
62.34; 90.38; 91.66; 91.40 | — |
| SECONDARY Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication |
52.56; 85.92; 88.56; 88.08 | — |
| SECONDARY Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) |
-18.8; -28.5; -34.9; -41.0; -46.6; -49.0 | < 0.0001 sig |
| SECONDARY Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) |
-39.2; -41.4; -40.5 | < 0.0001 sig |
| SECONDARY Change From Baseline in Mean Daily Sleep Interference Score (DSIS) |
-1.0; -1.8; -2.5; -2.8; -3.0; -3.1 | < 0.0001 sig |
| SECONDARY Patient Global Impression of Change (PGIC) |
37; 53; 12; 1; 0; 0 | — |
| SECONDARY Clinical Global Impression of Change (CGIC) |
41; 55; 5; 2; 0; 0 | — |
Summary
Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00407511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.