Phase 3
Completed N=123
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
Diabetic Neuropathy, Painful
Source: ClinicalTrials.gov NCT00553280 ↗
Enrolled (actual)
123
Serious AEs
17.1%
Results posted
Jan 2011
Primary outcomePrimary: Summary of Adverse Events — 114; 21; 7; 17 participants
Summary
The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Adverse Events |
114; 21; 7; 17; 43 | — |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores |
-3.5 | — |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores |
-1.2 | — |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores |
-4.7 | — |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores |
-25.4 | — |
| SECONDARY Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores |
-0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A0081163.
- 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 (A0081163) 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 (A0081163)
Data sourced from ClinicalTrials.gov (NCT00553280). 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.