Clinical trial NCT00313820: Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Neuropathic Pain
Keywords: Post-stroke pain, pregabalin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS)
timeFrame: Up to Week 12
Secondary outcomes:
measure: Pain Score as Measured by DPRS
timeFrame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12
measure: Number of Subjects With at Least a 30% Reduction From Baseline in Mean Pain Score at Endpoint
timeFrame: Baseline, Week 12
measure: Number of Subjects With at Least a 50% Reduction From Baseline in Mean Pain Score at Endpoint
timeFrame: Baseline, Week 12
measure: Weekly Mean Sleep Interference Score From Daily Sleep Diary (Daily Sleep Interference Scale [DSIS])
timeFrame: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12
measure: Short Form-McGill Pain Questionnaire (SF-MPQ Visual Analog Scale [VAS]) - Part B Only
timeFrame: Week 12
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Week 12
measure: Medical Outcome Study (MOS) Sleep Scale
timeFrame: Week 12
measure: Number of Subjects With Yes or No Response for Medical Outcome Study (MOS) Sleep Scale - Optimal Sleep
timeFrame: Week 12
measure: Hospital Anxiety and Depression Scale (HADS) - ITT Population
timeFrame: Week 12
measure: Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
timeFrame: Week 12
measure: EQ-5D - VAS
timeFrame: Week 12
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 12
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Week 12
measure: Quantitative Assessment of Neuropathic Pain (QANeP) - Sensory Threshold
timeFrame: Baseline, Week 12
measure: QANeP - Pain Rating Scales
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: East Gosford
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Warrawong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Footscray
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Guang Zhou
country: China
facility: Pfizer Investigational Site
city: Shang Hai
country: China
facility: Pfizer Investigational Site
city: Shang Hai
country: China
facility: Pfizer Investigational Site
city: New Territories
country: Hong Kong
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
city: Chennai
country: India
facility: Pfizer Investigational Site
city: Lucknow
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Jakarta
country: Indonesia
facility: Pfizer Investigational Site
city: Surabaya
country: Indonesia
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Penang
country: Malaysia
facility: Pfizer Investigational Site
city: Selangor
country: Malaysia
facility: Pfizer Investigational Site
city: Karachi
country: Pakistan
facility: Pfizer Investigational Site
state: Sindh
city: Karachi
country: Pakistan
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Gueishan Shiang
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan Hsien
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Ratchatewee
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: