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Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Central Neuropathic Pain

Intervention: Pregabalin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)

Clinical Details

Official title: A 13-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150-600 Mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Central Post-Stroke Pain (CPSP)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)

Secondary outcome:

Pain Score as Measured by DPRS

Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint

Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint

Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])

Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only

Neuropathic Pain Symptom Inventory (NPSI)

Medical Outcome Study (MOS) Sleep Scale

Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep

Hospital Anxiety and Depression Scale (HADS) - ITT Population

Euro Quality of Life (EQ-5D)- Health State Profile Utility Score

EQ-5D - VAS

Patient Global Impression of Change (PGIC)

Clinical Global Impression of Change (CGIC)

Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold

QANeP - Pain Rating Scales

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Positive history of clinical stroke at least 4 months prior to randomization CPSP--3

months prior to screening Exclusion Criteria:

- History of dementia or any other severe cognitive impairment

- Diabetic Peripheral Neuropathy (DPN)

Locations and Contacts

Pfizer Investigational Site, Beijing 100730, China

Pfizer Investigational Site, Beijing 100083, China

Pfizer Investigational Site, Guang Zhou 510180, China

Pfizer Investigational Site, Shang Hai 200003, China

Pfizer Investigational Site, Shang Hai 200040, China

Pfizer Investigational Site, New Territories, Hong Kong

Pfizer Investigational Site, Bangalore 560 034, India

Pfizer Investigational Site, Bangalore 560 054, India

Pfizer Investigational Site, Chennai 600 010, India

Pfizer Investigational Site, Lucknow 226 014, India

Pfizer Investigational Site, New Delhi 110 002, India

Pfizer Investigational Site, Jakarta 10430, Indonesia

Pfizer Investigational Site, Surabaya 60286, Indonesia

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of

Pfizer Investigational Site, Kuala Lumpur 59100, Malaysia

Pfizer Investigational Site, Penang 11600, Malaysia

Pfizer Investigational Site, Selangor 68100, Malaysia

Pfizer Investigational Site, Karachi, Pakistan

Pfizer Investigational Site, Manila 1000, Philippines

Pfizer Investigational Site, Manila 1003, Philippines

Pfizer Investigational Site, Taichung 407, Taiwan

Pfizer Investigational Site, Taipei 112, Taiwan

Pfizer Investigational Site, Bangkok 10400, Thailand

Pfizer Investigational Site, Ratchatewee, Bangkok 10400, Thailand

Pfizer Investigational Site, Darlinghurst, New South Wales 2010, Australia

Pfizer Investigational Site, East Gosford, New South Wales 2250, Australia

Pfizer Investigational Site, St Leonards, New South Wales 2065, Australia

Pfizer Investigational Site, Warrawong, New South Wales 2502, Australia

Pfizer Investigational Site, Herston, Queensland, Australia

Pfizer Investigational Site, Karachi, Sindh, Pakistan

Pfizer Investigational Site, Gueishan Shiang, Taoyuan Hsien, Taiwan

Pfizer Investigational Site, Footscray, Victoria 3011, Australia

Pfizer Investigational Site, Perth, Western Australia 6000, Australia

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2006
Last updated: October 9, 2009

Page last updated: August 23, 2015

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