Phase 3
Completed N=126
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
Neuralgia, Postherpetic
Source: ClinicalTrials.gov NCT00424372 ↗
Enrolled (actual)
126
Serious AEs
11.9%
Results posted
Sep 2009
Primary outcomePrimary: Summary of Adverse Events — 124; 14; 5; 17 subjects
Summary
To evaluate the safety of the long-term use of pregabalin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Adverse Events |
124; 14; 5; 17; 34 | — |
| SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score |
11.3; 5.1; 6.7; -4.8 | — |
| SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score |
3.4; 1.0; 1.7; -1.8 | — |
| SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score |
14.7; 6.1; 8.2; -6.5 | — |
| SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity |
2.8; 1.4; 1.7; -1.1 | — |
| SECONDARY Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale |
62.0; 28.3; 33.7; -28.3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.
- Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.
Exclusion Criteria
- Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.
- Patients exhibiting treatment non-compliance in the preceding study (A0081120)
Data sourced from ClinicalTrials.gov (NCT00424372). 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. Informational only — not medical advice.