Back to resultsA Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
Primary Purpose
Postherpetic Neuralgia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pregabalin
pregabalin/PF-00489791
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia
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
Sites / Locations
- North Alabama RadioPharmacy
- Tennessee Valley Pain Consultants
- River Region Research, LLC
- Radiant Research
- Novara Clinical Research
- Community Medical Providers
- Sierra Medical Research (Administrative only site)
- Prime-Care Clinical Research
- Parkinson's Disease and Movement Disorders Center of Boca Raton
- Bradenton Research Center
- Arthritis Associates of South Florida
- Delray Research Associates
- Office of Laszlo J Mate, M.D.
- American Medical Research, Inc.
- Beacon Clinical Research
- ICPS Group
- Neurological Research Center at Hattiesburg Clinic
- CRC of Jackson
- Physician's Surgery Center
- Clinvest
- Centennial Park Medical Building
- Neurology Associates of Great Plains
- Finger Lakes Clinical Research
- North State Clinical Research, PLLC
- The Center for Clinical Research
- Legacy Pharma Research
- Patient Priority Clinical Sites, LLC
- Lynn Health Science Institute
- Mark A. Fisher, MD-Private Practice
- Absolute Primary Care, P.C.
- John P. Murtha Neuroscience and Pain Institute
- Memorial Medical Center
- New England Center for Clinical Research
- Medical Clinic of North Texas
- FutureSearch Trials of Neurology
- Futuresearch Trials
- Pinnacle Pain Medicine
- The Medical Group Of Texas
- Medical and Surgical Clinic of Irving
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants With Patient Global Impression of Change (PGIC) Score
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.
Pain Visual Analogue Scale (VAS) at Baseline and 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.
Neuropathic Pain Symptom Inventory (NPSI)
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
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
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.
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
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: Clinical Chemistry
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.
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00599638
Brief Title
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
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 9, 2008 (Actual)
Primary Completion Date
December 16, 2008 (Actual)
Study Completion Date
December 23, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
75mg bid titrating to 150mg bid on day 4
Intervention Type
Drug
Intervention Name(s)
pregabalin/PF-00489791
Intervention Description
Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Mean Pain Score on Daily Pain Rating Scale (DPRS)
Description
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.
Time Frame
End of treatment period (included both Week 2 and Week 6)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Patient Global Impression of Change (PGIC) Score
Description
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.
Time Frame
End of treatment period (included both Week 2 and Week 6)
Title
Pain Visual Analogue Scale (VAS) at Baseline and Week 4
Description
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.
Time Frame
Baseline, Week 4
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
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.
Time Frame
End of treatment period (included both Week 2 and Week 6)
Title
Number of Participants With Clinically Significant Vital Signs Abnormalities
Description
Vital signs abnormalities included sitting, standing: systolic, diastolic blood pressure and heart rate. Clinical significance was judged by investigator.
Time Frame
Baseline up to Week 7
Title
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description
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.
Time Frame
Baseline up to Week 7
Title
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Description
Criteria for hematology abnormalities included Hemoglobin: <0.8*lower limit of normal (LLN) and hematocrit: <0.8*LLN. Clinical significance was judged by investigator.
Time Frame
Baseline up to Week 7
Title
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry
Description
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.
Time Frame
Baseline up to Week 7
Title
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Description
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.
Time Frame
Baseline up to Week 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
North Alabama RadioPharmacy
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Tennessee Valley Pain Consultants
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
River Region Research, LLC
City
Tallassee
State/Province
Alabama
ZIP/Postal Code
36078
Country
United States
Facility Name
Radiant Research
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Novara Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Community Medical Providers
City
Clovis
State/Province
California
ZIP/Postal Code
93611
Country
United States
Facility Name
Sierra Medical Research (Administrative only site)
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Prime-Care Clinical Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Bradenton Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Arthritis Associates of South Florida
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Delray Research Associates
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Office of Laszlo J Mate, M.D.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
American Medical Research, Inc.
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Beacon Clinical Research
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
ICPS Group
City
Norwood
State/Province
Massachusetts
ZIP/Postal Code
02062
Country
United States
Facility Name
Neurological Research Center at Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401-7246
Country
United States
Facility Name
CRC of Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Physician's Surgery Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Centennial Park Medical Building
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
Facility Name
Neurology Associates of Great Plains
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
North State Clinical Research, PLLC
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Legacy Pharma Research
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Patient Priority Clinical Sites, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Mark A. Fisher, MD-Private Practice
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Absolute Primary Care, P.C.
City
Cranberry Twp.
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
John P. Murtha Neuroscience and Pain Institute
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States
Facility Name
Memorial Medical Center
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
New England Center for Clinical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Medical Clinic of North Texas
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Futuresearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Pinnacle Pain Medicine
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
The Medical Group Of Texas
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Medical and Surgical Clinic of Irving
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0261002&StudyName=A%20Study%20To%20Compare%20Pregabalin/PF-00489791%20Combination%20Versus%20Pregabalin%20Alone%20In%20Post-Herpetic%20Neuralgia
Description
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Learn more about this trial
A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
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