A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

Study Overview
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Brief Summary
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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)

Official Title
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Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

Conditions
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Painful Diabetic Neuropathy and Post Herpetic Neuralgia

Intervention / Treatment
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* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pregabalin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| CGIC and PGIC |  | End of treatment | 
| 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 |