A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
- Conditions
- Postherpetic Neuralgia
- Interventions
- Registration Number
- NCT00599638
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 pregabalin/PF-00489791 - 3 Placebo - 1 pregabalin -
- Primary Outcome Measures
Name Time Method Mean Pain Score on Daily Pain Rating Scale (DPRS) End of treatment period (included both Week 2 and Week 6) Pain was assessed by using a daily pain rating scale that consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"), higher scores indicate more pain intensity. Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily. The mean pain score was defined as the mean of the last 7 daily pain ratings scale scores while taking study medication, at end of each treatment period: Period 1 (Week 2) and Period 2 (Week 6), respectively. Mean pain score had a score range of 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain. Cumulative data of mean pain scores at end of treatment for both the periods was calculated and reported in terms of adjusted mean and standard error.
- Secondary Outcome Measures
Name Time Method Neuropathic Pain Symptom Inventory (NPSI) End of treatment period (included both Week 2 and Week 6) Participant rated 10-item questionnaire to evaluate different symptoms of neuropathic pain (spontaneous pain like \[item 1 to 3\]: burning, squeezing, pressure; painful attack like \[item 4 to 5\]: electric shock, stabbing; pain provoked on \[item 6 to 8\]: light touching, pressure, contact with something cold; abnormal sensations like \[item 9 to 10\]: pins and needles, tingling). Each item was rated on an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity of pain). Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. Cumulative data of NPSI scale at end of treatment for both the periods (Period 1 \[Week 2\] and Period 2 \[Week 6\]) was calculated and reported in terms of adjusted mean and standard error.
Number of Participants With Clinically Significant Vital Signs Abnormalities Baseline up to Week 7 Vital signs abnormalities included sitting, standing: systolic, diastolic blood pressure and heart rate. Clinical significance was judged by investigator.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities Baseline up to Week 7 Criteria for ECG abnormalities: Maximum QTc (corrected QT) interval, QTcB (Bazett's correction formula) and QTcF (Fridericia's correction formula): 450 to less than (\<) 480 milliseconds (msec), 480 to \<500 msec and greater than equal to (\>=) 500 msec; Maximum QTc interval increase from baseline: \>=30 to \<60 and \>=60 (msec); PR interval: \>=300 msec and percent change \>=25 or 50 percent; QRS complex: percent change \>=25 or 50 percent. Clinical significance was judged by investigator.
Percentage of Participants With Patient Global Impression of Change (PGIC) Score End of treatment period (included both Week 2 and Week 6) The PGIC is a participant-rated instrument that measures change in the participants' overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse), lower scores indicated more improvement. PGIC was evaluated using 3 categories: improvement (scores 1-3), no change (score 4), and worsening (scores 5-7). In this outcome measure percentage of participants with categories: improved, no change and worsening, based on PGIC score were reported. Cumulative data at end of treatment for both the periods (Period 1 \[Week 2\] and Period 2 \[Week6\]) was calculated and reported.
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology Baseline up to Week 7 Criteria for hematology abnormalities included Hemoglobin: \<0.8\*lower limit of normal (LLN) and hematocrit: \<0.8\*LLN. Clinical significance was judged by investigator.
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis Baseline up to Week 7 Urinalysis abnormalities criteria included: urine specific gravity: \<1.003 to \>1.030; urine pH: \<4.5 to \>8; urine glucose, urine ketones, urine proteins, urine blood/hemoglobin: \>=1. Clinical significance was judged by investigator.
Pain Visual Analogue Scale (VAS) at Baseline and Week 4 Baseline, Week 4 Participants marked intensity of the pain on a scale, ranging from 0 millimeters (mm) = no pain to 100 mm = worst possible pain, where higher scores indicate more pain.
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry Baseline up to Week 7 Criteria for clinical chemistry abnormalities included total bilirubin: greater than (\>) 1.5\*upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase: \>3.0\*ULN; total protein, albumin: \<0.8\*LLN or \>1.2\*ULN; blood urea nitrogen, creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; sodium: \<0.95\*LLN or \>1.05\*ULN; potassium, chloride, calcium: \<0.9\*LLN or \>1.1\*ULN; creatine kinase: \>2.0\*ULN. Clinical significance was judged by investigator.
Trial Locations
- Locations (39)
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Arthritis Associates of South Florida
🇺🇸Delray Beach, Florida, United States
Delray Research Associates
🇺🇸Delray Beach, Florida, United States
Office of Laszlo J Mate, M.D.
🇺🇸West Palm Beach, Florida, United States
Mark A. Fisher, MD-Private Practice
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
North Alabama RadioPharmacy
🇺🇸Huntsville, Alabama, United States
Tennessee Valley Pain Consultants
🇺🇸Huntsville, Alabama, United States
River Region Research, LLC
🇺🇸Tallassee, Alabama, United States
Sierra Medical Research (Administrative only site)
🇺🇸Fresno, California, United States
Prime-Care Clinical Research
🇺🇸Mission Viejo, California, United States
Bradenton Research Center
🇺🇸Bradenton, Florida, United States
American Medical Research, Inc.
🇺🇸Oak Brook, Illinois, United States
Beacon Clinical Research
🇺🇸Brockton, Massachusetts, United States
ICPS Group
🇺🇸Norwood, Massachusetts, United States
CRC of Jackson
🇺🇸Jackson, Mississippi, United States
Physician's Surgery Center
🇺🇸Jackson, Mississippi, United States
Clinvest
🇺🇸Springfield, Missouri, United States
Centennial Park Medical Building
🇺🇸North Platte, Nebraska, United States
Neurology Associates of Great Plains
🇺🇸North Platte, Nebraska, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
North State Clinical Research, PLLC
🇺🇸Lenoir, North Carolina, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Legacy Pharma Research
🇺🇸Bismarck, North Dakota, United States
Patient Priority Clinical Sites, LLC
🇺🇸Cincinnati, Ohio, United States
Absolute Primary Care, P.C.
🇺🇸Cranberry Twp., Pennsylvania, United States
Memorial Medical Center
🇺🇸Johnstown, Pennsylvania, United States
John P. Murtha Neuroscience and Pain Institute
🇺🇸Johnstown, Pennsylvania, United States
Medical Clinic of North Texas
🇺🇸Arlington, Texas, United States
New England Center for Clinical Research
🇺🇸Cranston, Rhode Island, United States
Futuresearch Trials
🇺🇸Austin, Texas, United States
Pinnacle Pain Medicine
🇺🇸Dallas, Texas, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
The Medical Group Of Texas
🇺🇸Fort Worth, Texas, United States
Medical and Surgical Clinic of Irving
🇺🇸Irving, Texas, United States
Neurological Research Center at Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Community Medical Providers
🇺🇸Clovis, California, United States
Novara Clinical Research
🇺🇸Mesa, Arizona, United States
Radiant Research
🇺🇸Chandler, Arizona, United States