Clinical trial NCT00599638: A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
Official title: A TWO WEEK DOUBLE-BLIND PLACEBO-CONTROLLED CROSSOVER STUDY TO COMPARE THE EFFICACY AND SAFETY OF A PREGABALIN/PF-00489791 COMBINATION VERSUS PREGABALIN ALONE IN PATIENTS WITH POST-HERPETIC NEURALGIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.


Eligibility criteria: Inclusion Criteria:

* Male or female of non-childbearing potential
* Pain present for more than 3 months after healing of herpes zoster skin rash
* VAS score of \>=40mm at screening and baseline visits

Exclusion Criteria:

* Patients with pain conditions which might impair the assessment of postherpetic neuralgia
* Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia
* History or diagnosis of DSM IV major depressive disorder

Primary outcomes:
measure: Mean Pain Score on Daily Pain Rating Scale (DPRS)
timeFrame: End of treatment period (included both Week 2 and Week 6)
Secondary outcomes:
measure: Percentage of Participants With Patient Global Impression of Change (PGIC) Score
timeFrame: End of treatment period (included both Week 2 and Week 6)
measure: Pain Visual Analogue Scale (VAS) at Baseline and Week 4
timeFrame: Baseline, Week 4
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: End of treatment period (included both Week 2 and Week 6)
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to Week 7
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Week 7
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
timeFrame: Baseline up to Week 7
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry
timeFrame: Baseline up to Week 7
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
timeFrame: Baseline up to Week 7
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: North Alabama RadioPharmacy
state: Alabama
city: Huntsville
country: United States
facility: Tennessee Valley Pain Consultants
state: Alabama
city: Tallassee
country: United States
facility: River Region Research, LLC
state: Alabama
city: Chandler
country: United States
facility: Radiant Research
state: Arizona
city: Mesa
country: United States
facility: Novara Clinical Research
state: Arizona
city: Clovis
country: United States
facility: Community Medical Providers
state: California
city: Fresno
country: United States
facility: Sierra Medical Research (Administrative only site)
state: California
city: Mission Viejo
country: United States
facility: Prime-Care Clinical Research
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center
state: Florida
city: Delray Beach
country: United States
facility: Arthritis Associates of South Florida
state: Florida
city: Delray Beach
country: United States
facility: Delray Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Office of Laszlo J Mate, M.D.
state: Florida
city: Oak Brook
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Brockton
country: United States
facility: Beacon Clinical Research
state: Massachusetts
city: Norwood
country: United States
facility: ICPS Group
state: Massachusetts
city: Hattiesburg
country: United States
facility: Neurological Research Center at Hattiesburg Clinic
state: Mississippi
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: Jackson
country: United States
facility: Physician's Surgery Center
state: Mississippi
city: Springfield
country: United States
facility: Clinvest
state: Missouri
city: North Platte
country: United States
facility: Centennial Park Medical Building
state: Nebraska
city: North Platte
country: United States
facility: Neurology Associates of Great Plains
state: Nebraska
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Lenoir
country: United States
facility: North State Clinical Research, PLLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Bismarck
country: United States
facility: Legacy Pharma Research
state: North Dakota
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mark A. Fisher, MD-Private Practice
state: Oklahoma
city: Cranberry Twp.
country: United States
facility: Absolute Primary Care, P.C.
state: Pennsylvania
city: Johnstown
country: United States
facility: John P. Murtha Neuroscience and Pain Institute
state: Pennsylvania
city: Johnstown
country: United States
facility: Memorial Medical Center
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Arlington
country: United States
facility: Medical Clinic of North Texas
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Austin
country: United States
facility: Futuresearch Trials
state: Texas
city: Dallas
country: United States
facility: Pinnacle Pain Medicine
state: Texas
city: Fort Worth
country: United States
facility: The Medical Group Of Texas
state: Texas
city: Irving
country: United States
facility: Medical and Surgical Clinic of Irving
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: