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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | 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. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Aachen | 52064 | Germany | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| 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 |
| Albstadt |
| 72458 |
| Germany |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Berlin | 10435 | Germany |
| Pfizer Investigational Site | Berlin | 13053 | Germany |
| Pfizer Investigational Site | Bielefeld | 33604 | Germany |
| Pfizer Investigational Site | Celle | 29221 | Germany |
| Pfizer Investigational Site | Deggingen | 73326 | Germany |
| Pfizer Investigational Site | Duisburg | 47051 | Germany |
| Pfizer Investigational Site | Erbach im Odenwald | 64711 | Germany |
| Pfizer Investigational Site | Erfurt | 99089 | Germany |
| Pfizer Investigational Site | Frankfurt | 60311 | Germany |
| Pfizer Investigational Site | Gera | 07548 | Germany |
| Pfizer Investigational Site | Göppingen | 73033 | Germany |
| Pfizer Investigational Site | Hamburg | 21073 | Germany |
| Pfizer Investigational Site | Hamburg | 22149 | Germany |
| Pfizer Investigational Site | Hamburg | 22607 | Germany |
| Pfizer Investigational Site | Hemsbach | 69502 | Germany |
| Pfizer Investigational Site | Hildesheim | 31134 | Germany |
| Pfizer Investigational Site | Holle | 31188 | Germany |
| Pfizer Investigational Site | Itzehoe | 25524 | Germany |
| Pfizer Investigational Site | Karlsruhe | 76133 | Germany |
| Pfizer Investigational Site | Karlsruhe | 76199 | Germany |
| Pfizer Investigational Site | Katzhütte | 98746 | Germany |
| Pfizer Investigational Site | Leer | 26789 | Germany |
| Pfizer Investigational Site | Leipzig | 04103 | Germany |
| Pfizer Investigational Site | Limburgerhof | 67117 | Germany |
| Pfizer Investigational Site | Ludwigshafen | 67061 | Germany |
| Pfizer Investigational Site | Ludwigshafen | 67069 | Germany |
| Pfizer Investigational Site | Lübeck | 23552 | Germany |
| Pfizer Investigational Site | Lünen | 44534 | Germany |
| Pfizer Investigational Site | Mainz | 55116 | Germany |
| Pfizer Investigational Site | Marl | 45768 | Germany |
| Pfizer Investigational Site | München | 81479 | Germany |
| Pfizer Investigational Site | Münster | 48129 | Germany |
| Pfizer Investigational Site | Osnabrück | 49078 | Germany |
| Pfizer Investigational Site | Recklinghausen | 45657 | Germany |
| Pfizer Investigational Site | Senftenberg | 01968 | Germany |
| Pfizer Investigational Site | Sinsheim | 74889 | Germany |
| Pfizer Investigational Site | Surwold | 26903 | Germany |
| Pfizer Investigational Site | Unterhaching | 82008 | Germany |
| Pfizer Investigational Site | Veitsbronn | 90587 | Germany |
| Pfizer Investigational Site | Weimar | 99425 | Germany |
| Pfizer Investigational Site | Wiesbaden | 65191 | Germany |
| Pfizer Investigational Site | Witten | 58452 | Germany |
| Pfizer Investigational Site | Zwönitz | 08297 | Germany |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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