Phase 3
N=256
Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.
Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00219544 ↗Enrolled (actual)
256
Serious AEs
—
Results posted
Jun 2009
Primary outcome: Primary: Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase — 2.84; 3.62 score on scale — p=0.0018
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (Lyrica) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase |
2.84; 3.62 | 0.0018 sig |
| SECONDARY Weekly Mean Pain Scores During the Single-blind Treatment Phase |
6.29; 3.79 | — |
| SECONDARY Weekly Mean Pain Scores During the Double Blind Treatment Phase |
2.68; 2.49; 2.62; 3.14; 2.75; 3.40 | — |
| SECONDARY Change in Pain Scores During Double Blind Treatment Phase |
-0.01; 0.71; 0.08; 1.05; -0.06; 0.87 | 0.0010 sig |
| SECONDARY Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment |
165; 90 | — |
| SECONDARY Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment. |
-3.60 | — |
| SECONDARY Mean Pain Score for Non-responders at End of Single-blind Treatment Phase |
-0.49 | — |
| SECONDARY Categorized Daily Pain Score |
3.3; 0.9; 19.5; 17.4; 7.4; 8.6 | — |
| SECONDARY Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants) |
28; 28 | — |
| SECONDARY Mean Sleep Interference Score |
1.81; 2.52 | 0.0031 sig |
| SECONDARY Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase |
4.80; 2.72 | — |
| SECONDARY Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase |
1.68; 1.62; 1.76; 2.24; 1.85; 2.53 | — |
| SECONDARY Change in Sleep Interference Scores During Double Blind Treatment Phase |
0.07; 0.59; 0.10; 0.97; -0.03; 0.78 | 0.0177 sig |
| SECONDARY Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS) |
6.9; 15.9 | 0.0069 sig |
| SECONDARY Change in Hospital Anxiety and Depression Scale Responses |
-0.1; 1.2; -0.4; 0.8 | 0.0023 sig |
| SECONDARY Change in Pain Treatment Satisfaction Scale (PTSS) |
-1.96; -7.95; -1.86; -8.35 | 0.0828 |
| SECONDARY Patient Global Impression of Change (PGIC) Categories by Number of Subjects |
21; 12; 35; 32; 15; 17 | 0.0278 sig |
| SECONDARY Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity. |
0.16; 0.92; 0.29; 1.06 | 0.0049 sig |
| SECONDARY Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components |
-0.01; -0.07; -0.03; -2.09 | 0.0719 |
Summary
This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).
Eligibility Criteria
Inclusion Criteria
- Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
- At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.
Exclusion Criteria
- Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.
Data sourced from ClinicalTrials.gov (NCT00219544). 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.