Phase 2
N=72
A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
Postherpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT00599638 ↗Enrolled (actual)
72
Serious AEs
0.8%
Results posted
Aug 2021
Primary outcome: Primary: Mean Pain Score on Daily Pain Rating Scale (DPRS) — 4.32; 4.22; 5.57 units on a scale — p=0.3910
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pregabalin (Drug); pregabalin/PF-00489791 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pain Score on Daily Pain Rating Scale (DPRS) |
4.32; 4.22; 5.57 | 0.3910 |
| SECONDARY Percentage of Participants With Patient Global Impression of Change (PGIC) Score |
77.42; 77.78; 39.13; 16.13; 18.52; 43.48 | 0.4959 |
| SECONDARY Pain Visual Analogue Scale (VAS) at Baseline and Week 4 |
66.48; 65.92; 67.92; 60.88; 63.79; 55.92 | — |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) |
25.71; 25.87; 35.25 | 0.3380 |
| SECONDARY Number of Participants With Clinically Significant Vital Signs Abnormalities |
0; 2; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities |
1; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry |
0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis |
0; 0; 0 | — |
Summary
Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.
Eligibility Criteria
Inclusion Criteria
- Male or female of non-childbearing potential
- Pain present for more than 3 months after healing of herpes zoster skin rash
- VAS score of >=40mm at screening and baseline visits
Exclusion Criteria
- Patients with pain conditions which might impair the assessment of postherpetic neuralgia
- Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
- History or diagnosis of DSM IV major depressive disorder
Data sourced from ClinicalTrials.gov (NCT00599638). 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.