Clinical trial NCT00219544: Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.
Official title: A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuropathic Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 158
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: This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).


Eligibility criteria: Inclusion Criteria:

* Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
* At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.

Exclusion Criteria:

* Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.

Primary outcomes:
measure: Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase
timeFrame: 9 weeks
Secondary outcomes:
measure: Weekly Mean Pain Scores During the Single-blind Treatment Phase
timeFrame: 0 and 4 weeks
measure: Weekly Mean Pain Scores During the Double Blind Treatment Phase
timeFrame: Week 4 - 9
measure: Change in Pain Scores During Double Blind Treatment Phase
timeFrame: 9 weeks
measure: Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment
timeFrame: Week 4 (end of single-blind treatment phase)
measure: Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.
timeFrame: Week 4
measure: Mean Pain Score for Non-responders at End of Single-blind Treatment Phase
timeFrame: Week 4
measure: Categorized Daily Pain Score
timeFrame: Week 9
measure: Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)
timeFrame: Week 9
measure: Mean Sleep Interference Score
timeFrame: Week 9
measure: Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase
timeFrame: 0 and 4 weeks
measure: Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase
timeFrame: Week 9
measure: Change in Sleep Interference Scores During Double Blind Treatment Phase
timeFrame: 9 weeks
measure: Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)
timeFrame: Week 4, Week 9
measure: Change in Hospital Anxiety and Depression Scale Responses
timeFrame: Week 9
measure: Change in Pain Treatment Satisfaction Scale (PTSS)
timeFrame: Week 9
measure: Patient Global Impression of Change (PGIC) Categories by Number of Subjects
timeFrame: Week 9
measure: Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.
timeFrame: Week 9
measure: Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components
timeFrame: Week 9
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Port Hope
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Granby
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Levis
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Mirabel
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrook
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: