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

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.

Study Overview

• Status: Completed
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: Placebo; Drug: pregabalin; Drug: pregabalin/PF-00489791

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Tennessee Valley Pain Consultants
    • Huntsville, Alabama, United States, 35801
      • North Alabama RadioPharmacy
    • Tallassee, Alabama, United States, 36078
      • River Region Research, LLC
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Radiant Research
    • Mesa, Arizona, United States, 85206
      • Novara Clinical Research
  • California
    • Clovis, California, United States, 93611
      • Community Medical Providers
    • Fresno, California, United States, 93710
      • Sierra Medical Research (Administrative only site)
    • Mission Viejo, California, United States, 92691
      • Prime-Care Clinical Research
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center
    • Delray Beach, Florida, United States, 33484
      • Arthritis Associates of South Florida
    • Delray Beach, Florida, United States, 33484
      • Delray Research Associates
    • West Palm Beach, Florida, United States, 33407
      • Office of Laszlo J Mate, M.D.
  • Illinois
    • Oak Brook, Illinois, United States, 60523
      • American Medical Research, Inc.
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research
    • Norwood, Massachusetts, United States, 02062
      • ICPS Group
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401-7246
      • Neurological Research Center at Hattiesburg Clinic
    • Jackson, Mississippi, United States, 39202
      • CRC of Jackson
    • Jackson, Mississippi, United States, 39202
      • Physician's Surgery Center
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest
  • Nebraska
    • North Platte, Nebraska, United States, 69101
      • Centennial Park Medical Building
    • North Platte, Nebraska, United States, 69101
      • Neurology Associates of Great Plains
  • New York
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • North Carolina
    • Lenoir, North Carolina, United States, 28645
      • North State Clinical Research, PLLC
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Legacy Pharma Research
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Patient Priority Clinical Sites, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73112
      • Mark A. Fisher, MD-Private Practice
  • Pennsylvania
    • Cranberry Twp., Pennsylvania, United States, 16066
      • Absolute Primary Care, P.C.
    • Johnstown, Pennsylvania, United States, 15904
      • John P. Murtha Neuroscience and Pain Institute
    • Johnstown, Pennsylvania, United States, 15905
      • Memorial Medical Center
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • New England Center for Clinical Research
  • Texas
    • Arlington, Texas, United States, 76012
      • Medical Clinic of North Texas
    • Austin, Texas, United States, 78756
      • FutureSearch Trials
    • Austin, Texas, United States, 78756
      • FutureSearch Trials of Neurology
    • Dallas, Texas, United States, 75231
      • Pinnacle Pain Medicine
    • Fort Worth, Texas, United States, 76104
      • The Medical Group Of Texas
    • Irving, Texas, United States, 75061
      • Medical and Surgical Clinic of Irving

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1	Drug: pregabalin; 75mg bid titrating to 150mg bid on day 4
EXPERIMENTAL: 2	Drug: pregabalin/PF-00489791; Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
PLACEBO_COMPARATOR: 3	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	End of treatment period (included both Week 2 and Week 6)
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.	Baseline, Week 4
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.	End of treatment period (included both Week 2 and Week 6)
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.	Baseline up to Week 7
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.	Baseline up to Week 7
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.	Baseline up to Week 7
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.	Baseline up to Week 7
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.	Baseline up to Week 7

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 9, 2008
• Primary Completion (ACTUAL): December 16, 2008
• Study Completion (ACTUAL): December 23, 2008

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 11, 2008
• First Posted (ESTIMATE): January 24, 2008

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: B0261002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.