A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
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
1 other identifier
interventional
72
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 24, 2008
CompletedStudy Start
First participant enrolled
April 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2008
CompletedResults Posted
Study results publicly available
August 5, 2021
CompletedAugust 5, 2021
August 1, 2021
8 months
January 4, 2008
July 9, 2021
August 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Pain Score on Daily Pain Rating Scale (DPRS)
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.
End of treatment period (included both Week 2 and Week 6)
Secondary Outcomes (8)
Percentage of Participants With Patient Global Impression of Change (PGIC) Score
End of treatment period (included both Week 2 and Week 6)
Pain Visual Analogue Scale (VAS) at Baseline and Week 4
Baseline, Week 4
Neuropathic Pain Symptom Inventory (NPSI)
End of treatment period (included both Week 2 and Week 6)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Baseline up to Week 7
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Baseline up to Week 7
- +3 more secondary outcomes
Study Arms (3)
1
ACTIVE COMPARATOR2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (39)
North Alabama RadioPharmacy
Huntsville, Alabama, 35801, United States
Tennessee Valley Pain Consultants
Huntsville, Alabama, 35801, United States
River Region Research, LLC
Tallassee, Alabama, 36078, United States
Radiant Research
Chandler, Arizona, 85225, United States
Novara Clinical Research
Mesa, Arizona, 85206, United States
Community Medical Providers
Clovis, California, 93611, United States
Sierra Medical Research (Administrative only site)
Fresno, California, 93710, United States
Prime-Care Clinical Research
Mission Viejo, California, 92691, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
Bradenton Research Center
Bradenton, Florida, 34205, United States
Arthritis Associates of South Florida
Delray Beach, Florida, 33484, United States
Delray Research Associates
Delray Beach, Florida, 33484, United States
Office of Laszlo J Mate, M.D.
West Palm Beach, Florida, 33407, United States
American Medical Research, Inc.
Oak Brook, Illinois, 60523, United States
Beacon Clinical Research
Brockton, Massachusetts, 02301, United States
ICPS Group
Norwood, Massachusetts, 02062, United States
Neurological Research Center at Hattiesburg Clinic
Hattiesburg, Mississippi, 39401-7246, United States
CRC of Jackson
Jackson, Mississippi, 39202, United States
Physician's Surgery Center
Jackson, Mississippi, 39202, United States
Clinvest
Springfield, Missouri, 65807, United States
Centennial Park Medical Building
North Platte, Nebraska, 69101, United States
Neurology Associates of Great Plains
North Platte, Nebraska, 69101, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
North State Clinical Research, PLLC
Lenoir, North Carolina, 28645, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Legacy Pharma Research
Bismarck, North Dakota, 58501, United States
Patient Priority Clinical Sites, LLC
Cincinnati, Ohio, 45242, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Mark A. Fisher, MD-Private Practice
Oklahoma City, Oklahoma, 73112, United States
Absolute Primary Care, P.C.
Cranberry Twp., Pennsylvania, 16066, United States
John P. Murtha Neuroscience and Pain Institute
Johnstown, Pennsylvania, 15904, United States
Memorial Medical Center
Johnstown, Pennsylvania, 15905, United States
New England Center for Clinical Research
Cranston, Rhode Island, 02920, United States
Medical Clinic of North Texas
Arlington, Texas, 76012, United States
FutureSearch Trials of Neurology
Austin, Texas, 78756, United States
Futuresearch Trials
Austin, Texas, 78756, United States
Pinnacle Pain Medicine
Dallas, Texas, 75231, United States
The Medical Group Of Texas
Fort Worth, Texas, 76104, United States
Medical and Surgical Clinic of Irving
Irving, Texas, 75061, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 24, 2008
Study Start
April 9, 2008
Primary Completion
December 16, 2008
Study Completion
December 23, 2008
Last Updated
August 5, 2021
Results First Posted
August 5, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.