A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)

March 26, 2017 updated by: Pfizer

A Randomized Double Blind Placebo And Active Controlled Parallel Group Phase 2 Study To Evaluate PF-05089771 As A Monotherapy And As An Add-on To Pregabalin For The Treatment Of Painful Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)

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.
141

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
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85003
        • Clinical Research Consortium Arizona
    • California
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
    • Florida
      • Bradenton, Florida, United States, 34208
        • Meridien Research
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Brandon, Florida, United States, 33511
        • Pulmonary Associates of Brandon (PAB)
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Fort Myers, Florida, United States, 33912
        • Clinical Physiology Associates
      • Hallandale, Florida, United States, 33009
        • MD Clinical
      • Lakeland, Florida, United States, 33805
        • Meridien Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Ocala, Florida, United States, 34471
        • Family Care Specialists
      • Oviedo, Florida, United States, 32765
        • Oviedo Medical Research, LLC
      • St. Petersburg, Florida, United States, 33709
        • Meridien Research
      • Tampa, Florida, United States, 33634
        • Meridien Research
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute, Inc
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Clinical Research Advantage, Inc
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • New Bedford, Massachusetts, United States, 02740
        • Novex Clinical Research, LLC
      • Quincy, Massachusetts, United States, 02169
        • Beacon Clinical Research, LLC
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Head Pain and Neurological Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Clinical Research Consortium
    • New York
      • New York, New York, United States, 10128
        • The Medical Research Network, LLC
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • New Phase Research And Development
      • Tullahoma, Tennessee, United States, 37388
        • Internal Medicine Associates
      • Tullahoma, Tennessee, United States, 37388
        • Trinity Clinical Research, LLC
    • Texas
      • Arlington, Texas, United States, 76012
        • KRK Medical Research
      • Houston, Texas, United States, 77030
        • Nerve and Muscle Center of Texas
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Eastern Virginia Medical School
      • Norfolk, Virginia, United States, 23502
        • National Clinical Research - Norfolk, Inc
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center, Inc

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged 18 years to 80 years.
  • Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization.
  • Presence of ongoing pain due to DPN for at least 6 months.
  • Willing to discontinue protocol-specified prohibited pain medications for DPN throughout the duration of the study.

Exclusion Criteria:

  • Painful neuropathies or painful conditions other than DPN that may confound evaluation of pain due to DPN during the study.
  • Subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy.
  • Subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities.
  • Pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.

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: Parallel Assignment
  • Masking: Double

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.
Experimental: Placebo
Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Experimental: Pregabalin
Drug: Pregabalin 300 mg
Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Experimental: PF-05089771
Drug: PF-05089771 150 mg
PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Experimental: PF-05089771 + Pregabalin
Drug: PF-05089771 150 mg + Pregabalin 300 mg
PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.

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
Daily Pain Numeric Rating Scale (NRS)
Time Frame: Baseline, Week 1, Week 2, Week 3 and Week 4
The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.
Baseline, Week 1, Week 2, Week 3 and Week 4

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
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Time Frame: Baseline, Week 1, Week 2, Week 3 and Week 4
Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).
Baseline, Week 1, Week 2, Week 3 and Week 4
Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
Time Frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).
Baseline, Week 1, Week 2, Week 3, and Week 4
Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
Time Frame: Baseline, Week 2, and Week 4
Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Baseline, Week 2, and Week 4
Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
Time Frame: Baseline, Week 2 and Week 4
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Baseline, Week 2 and Week 4
Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
Time Frame: Baseline, Week 2, and Week 4
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Baseline, Week 2, and Week 4
Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
Time Frame: Baseline, Week 2 and Week 4
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Baseline, Week 2 and Week 4
Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia
Time Frame: Baseline, Week 2 and Week 4
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Baseline, Week 2 and Week 4
Neuropathic Pain Symptom Inventory (NPSI) - Total Score
Time Frame: Baseline, Week 2 and Week 4
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
Baseline, Week 2 and Week 4
Patient's Global Impression of Change Score (PGIC).
Time Frame: Baseline, Week 2, and Week 4
Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, "Improved", "No Change" and "Worse".
Baseline, Week 2, and Week 4
Daily Sleep Interference Scale Score (DSIS).
Time Frame: Baseline, Week 1, Week 2, Week 3 and Week 4
Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.
Baseline, Week 1, Week 2, Week 3 and Week 4
Total Amount of Rescue Medication Per Week
Time Frame: Baseline, Week 1, Week 2, Week 3, and Week 4
Total amount of rescue medication participants take per week
Baseline, Week 1, Week 2, Week 3, and Week 4
Number of Days Participants Take Rescue Medication
Time Frame: Baseline, Week 1, Week 2, Week 3 and Week 4
Number of days participants take rescue medication per week.
Baseline, Week 1, Week 2, Week 3 and Week 4
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)
Time Frame: Screening to Day 36, and Day 64
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.
Screening to Day 36, and Day 64
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time Frame: Screening, Day 1, Day 15 and Day 29
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.
Screening, Day 1, Day 15 and Day 29
Fasted Total Cholesterol Values
Time Frame: Baseline, Week 2 and Week 4
Percentage Change from Baseline in Fasted Total Cholesterol values
Baseline, Week 2 and Week 4
Fasted Low Density Lipoprotein (LDL) Cholesterol
Time Frame: Baseline, Week 2 and Week 4
Percentage Change from Baseline in LDL cholesterol Friedewald by PEG
Baseline, Week 2 and Week 4
Plasma Concentration of PF-05089771
Time Frame: Baseline, Week 2 and Week 4
All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.
Baseline, Week 2 and Week 4

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.
November 10, 2014

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.
July 15, 2015

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.
September 28, 2015

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).
August 11, 2014

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.
August 11, 2014

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.
August 13, 2014

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.
May 5, 2017

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.
March 26, 2017

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.
March 1, 2017

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.
  • B3291026
  • DPN NAV1.7 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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