A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00301223
First received: March 7, 2006
Last updated: May 4, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuropathic Pain |
Drug: Pregabalin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | An 8-Week Multi-Center, Randomized, Double Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150mg-600mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Symptoms Of Neuropathic Pain |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
Secondary Outcome Measures:
- 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)
- 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.
| Enrollment: | 309 |
| Study Start Date: | February 2006 |
| Study Completion Date: | September 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Chinese outpatient of age 18 to 75
- At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ
Exclusion Criteria:
- Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain
- Serum creatinine clearance greater than 60 ml/min
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301223
Locations
| China | |
| Pfizer Investigational Site | |
| Beijing, China | |
| Pfizer Investigational Site | |
| Cheng Du Si Chaun, China | |
| Pfizer Investigational Site | |
| Guang Zhou, China | |
| Pfizer Investigational Site | |
| Nan Jing, Jiang Su, China | |
| Pfizer Investigational Site | |
| Qing Dao Shan Dong, China | |
| Pfizer Investigational Site | |
| Shang Hai, China | |
| Pfizer Investigational Site | |
| Shanghai, China | |
| Pfizer Investigational Site | |
| Tian Jin, China | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00301223 History of Changes |
| Other Study ID Numbers: | A0081081 |
| Study First Received: | March 7, 2006 |
| Last Updated: | May 4, 2011 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Pregabalin |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 19, 2013