Phase 3
N=806
Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
Post Herpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT01270828 ↗Enrolled (actual)
806
Serious AEs
2.2%
Results posted
Jan 2016
Primary outcome: Primary: Number of Participants With Loss of Therapeutic Response. — 29; 63 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pregabalin (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
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Loss of Therapeutic Response. |
29; 63 | <0.0001 sig |
| SECONDARY Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results |
49; 87 | <0.0001 sig |
| SECONDARY Percentage of Participants With 30% Reduction in the Mean Pain Score. |
95.6; 83.8 | <0.0001 sig |
| SECONDARY Percentage of Participants With 50% Reduction in the Mean Pain Score. |
88.3; 68.6 | <0.0001 sig |
| SECONDARY Change From Baseline to Endpoint in Weekly Mean Pain Score. |
-4.89; -3.95; -0.04; 0.87 | <0.0001 sig |
| SECONDARY Change in the Weekly NRS-Pain (1-Week Recall). |
-5.0; -3.9; -0.1; 0.9 | <0.0001 sig |
| SECONDARY Change in the Medical Outcomes Study-Sleep Scale (MOS-SS). |
-19.9; -16.7; 1.2; 4.4; -21.2; -17.4 | 0.0324 sig |
| SECONDARY Change in the MOS-SS-Quantity of Sleep. |
0.9; 0.7; -0.1; -0.4 | 0.1635 |
| SECONDARY The MOS-SS-Optimal Sleep. |
58.7; 62.4; 54.9; 54.8 | 0.432 |
| SECONDARY Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score |
31.5; 23.1; 36.9; 30.3; 16.7; 19.0 | 0.0007 sig |
| SECONDARY Change in the Short Form 36 Health Survey (SF-36) |
7.5; 5.6; 0.1; -2.3; 6.4; 5.5 | 0.0003 sig |
| SECONDARY Change in Mean Daily Sleep Interference Scores |
-4.5; -3.5; -0.2; 0.7 | <0.0001 sig |
| SECONDARY Change in Hospital Anxiety and Depression Scales (HADS) |
-1.8; -1.1; 0.1; 0.9; -1.8; -1.2 | 0.0154 sig |
| SECONDARY Change in the Brief Pain Inventory (BPI-sf) |
-18.0; -13.8; -0.7; 3.1; -21.9; -17.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW) |
98.5; 93.3; 96.0; 90.7; 87.6; 81.3 | 0.0161 sig |
| SECONDARY Number of Participants With Adverse Events |
80; 63; 441; 7; 3; 17 | — |
| SECONDARY Percentage of Participants With Suicidal Behaviour/Ideation |
0; 0.5; 0; 0; 0; 0 | — |
Summary
The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)
Eligibility Criteria
Inclusion Criteria
- Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
- At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
- At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to 4.
- Male or female of any race, at least 18 years of age, and using appropriate methods of contraception
Exclusion Criteria
- Creatinine clearance <30 mL/min (estimated from serum creatinine).
- Skin conditions in the affected dermatome that could alter sensation
- Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin
Data sourced from ClinicalTrials.gov (NCT01270828). 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.