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The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries | ||
| The Short Form McGill Pain Questionnaire | ||
| The Sleep interference score (from subject pain diary) |
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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 | Beijing | China | ||||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28072797 | Derived | Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63. | |
| 27611736 | Derived | Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| The Clinician and Patient Global Impression of Change (CGIC and PGIC) |
| The responder rate defined as the proportion of subjects reporting a decrease of at least 30% in the weekly mean pain scores in each treatment group. |
| Addtionally, the safety and tolerability of Pregabalin will also be evaluated. |
| Cheng Du Si Chaun |
| China |
| Pfizer Investigational Site | Guangzhou | China |
| Pfizer Investigational Site | Nan Jing, Jiang Su | China |
| Pfizer Investigational Site | Qing Dao Shan Dong | China |
| Pfizer Investigational Site | Shanghai | China |
| Pfizer Investigational Site | Tianjin | China |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |