A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia

August 4, 2021 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Pain Score on Daily Pain Rating Scale (DPRS)
Time Frame: 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.
End of treatment period (included both Week 2 and Week 6)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Patient Global Impression of Change (PGIC) Score
Time Frame: 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.
End of treatment period (included both Week 2 and Week 6)
Pain Visual Analogue Scale (VAS) at Baseline and Week 4
Time Frame: 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.
Baseline, Week 4
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: 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.
End of treatment period (included both Week 2 and Week 6)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Time Frame: Baseline up to Week 7
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
Time Frame: 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.
Baseline up to Week 7
Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology
Time Frame: 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.
Baseline up to Week 7
Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry
Time Frame: 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.
Baseline up to Week 7
Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis
Time Frame: 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.
Baseline up to Week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2008

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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