Clinical trial NCT00292188: P4 (Pregabalin for Peripheral Posttraumatic Pain)
Official title: A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuralgia
Keywords: Phase 4, post-traumatic neuropathic pain, neuropathic pain, Nep, post surgical pain, nerve injury, phantom limb pain, international
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-15
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event

Exclusion Criteria:

* Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
* NeP not due to trauma, and not peripheral pain

Primary outcomes:
measure: Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary
timeFrame: each day of Week 8
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) Anxiety Score
timeFrame: Week 8
measure: Hospital Anxiety and Depression Scale (HADS) Depression Score
timeFrame: Week 8
measure: Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores
timeFrame: Week 8
measure: Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores
timeFrame: Week 8
measure: Weekly Mean Pain Score From Daily Pain Diary
timeFrame: Baseline through Week 8
measure: Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)
timeFrame: Baseline, Week 8
measure: Weekly Mean Sleep Interference Score
timeFrame: Week 8
measure: Medical Outcome Study (MOS) Sleep Subscales
timeFrame: Week 8
measure: Medical Outcome Study (MOS) Optimal Sleep
timeFrame: Week 8
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 8
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Week 8
measure: Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
timeFrame: Screening, Week 8
measure: Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
timeFrame: Screening, Week 8
measure: Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics
timeFrame: Screening, Week 8
measure: Pain Treatment Satisfaction Scale (PTSS): Efficacy
timeFrame: Screening, Week 8
measure: Modified Brief Pain Inventory Short Form (m-BPI-sf)
timeFrame: Baseline, Week 8
measure: Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score
timeFrame: Week 8
measure: Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning
timeFrame: Baseline, Week 8
measure: Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration
timeFrame: Baseline, Week 8
measure: Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion
timeFrame: Baseline, Week 8
measure: Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory
timeFrame: Baseline, Week 8
measure: Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention
timeFrame: Baseline, Week 8
measure: Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking
timeFrame: Baseline, Week 8
measure: Davidson Trauma Scale (DTS): Severity
timeFrame: Baseline, Week 8
measure: Davidson Trauma Scale (DTS): Frequency
timeFrame: Baseline, Week 8
measure: Davidson Trauma Scale (DTS): Total Score
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Liège
country: Belgium
facility: Pfizer Investigational Site
city: Pellenberg
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Aarhus C
country: Denmark
facility: Pfizer Investigational Site
city: Hvidovre
country: Denmark
facility: Pfizer Investigational Site
city: HUS
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Montescano (PV)
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Tilburg
country: Netherlands
facility: Pfizer Investigational Site
state: NB
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
state: NH
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Kampen
country: Netherlands
facility: Pfizer Investigational Site
city: Roosendaal
country: Netherlands
facility: Pfizer Investigational Site
city: Almada
country: Portugal
facility: Pfizer Investigational Site
city: Amadora
country: Portugal
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Funchal
country: Portugal
facility: Pfizer Investigational Site
city: Guimarães
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Bucharest
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Iasi
country: Romania
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Geneve 14
country: Switzerland
facility: Pfizer Investigational Site
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: van Seventer R, Serpell M, Bach FW, Morlion B, Zlateva G, Bushmakin AG, Cappelleri JC, Nimour M. Relationships between changes in pain severity and other patient-reported outcomes: an analysis in patients with posttraumatic peripheral neuropathic pain. Health Qual Life Outcomes. 2011 Mar 25;9:17. doi: 10.1186/1477-7525-9-17.