The purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
217
Pregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days.
Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters
Time frame: Baseline to Week 4
Mean sleep score from patient's daily sleep interference diary
Time frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Change from baseline in mean sleep score from patient's daily sleep interference diary
Time frame: End of treatment
Mean anxiety score from patient's daily anxiety diary
Time frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Adverse events
Time frame: 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28
Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score
Time frame: End of treatment
Median time to pain response profile
Time frame: Over the first week
CGIC and PGIC
Time frame: End of treatment
Change from baseline in EuroQOL (as measures by EQ-5D)
Time frame: End of treatment
Change from baseline in mean anxiety score from patient's daily anxiety diary
Time frame: End of treatment
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Pfizer Investigational Site
Aachen, Germany
Pfizer Investigational Site
Albstadt, Germany
Pfizer Investigational Site
Berlin, Germany
Pfizer Investigational Site
Berlin, Germany
Pfizer Investigational Site
Berlin, Germany
Pfizer Investigational Site
Bielefeld, Germany
Pfizer Investigational Site
Celle, Germany
Pfizer Investigational Site
Deggingen, Germany
Pfizer Investigational Site
Duisburg, Germany
Pfizer Investigational Site
Erbach im Odenwald, Germany
...and 36 more locations
Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score
Time frame: End of treatment
Course of mean pain score of patient's daily pain diary (NRS)
Time frame: Throughout the study