Painful Diabetic Neuropathy and Post Herpetic Neuralgia
Conditions
Brief summary
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)
Interventions
DRUGPregabalin
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.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of DPN or PHN * Score on the Numeric Rating Scale of at least 4/10
Exclusion criteria
* Hospitalized patients * Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Baseline to Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Mean sleep score from patient's daily sleep interference diary | 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 | End of treatment |
| Mean anxiety score from patient's daily anxiety diary | 14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28 |
| Adverse events | 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 | End of treatment |
| Median time to pain response profile | Over the first week |
| Change from baseline in EuroQOL (as measures by EQ-5D) | End of treatment |
| Change from baseline in mean anxiety score from patient's daily anxiety diary | End of treatment |
| Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score | End of treatment |
| Course of mean pain score of patient's daily pain diary (NRS) | Throughout the study |
| CGIC and PGIC | End of treatment |
Countries
Germany
Outcome results
None listed