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)

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: Completed
• Conditions: Diabetic Neuropathy, Painful
• Intervention / Treatment: Drug: PF-05089771 150 mg; Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg; Drug: Pregabalin 300 mg; Drug: PF-05089771 150 mg + Pregabalin 300 mg

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Daily Pain Numeric Rating Scale (NRS)	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

Outcome Measure	Measure Description	Time Frame
Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score	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	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	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	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	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	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	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	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).	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).	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	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	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)	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	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	Percentage Change from Baseline in Fasted Total Cholesterol values	Baseline, Week 2 and Week 4
Fasted Low Density Lipoprotein (LDL) Cholesterol	Percentage Change from Baseline in LDL cholesterol Friedewald by PEG	Baseline, Week 2 and Week 4
Plasma Concentration of PF-05089771	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

• 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): November 10, 2014
• Primary Completion (Actual): July 15, 2015
• Study Completion (Actual): September 28, 2015

Study Registration Dates

• First Submitted: August 11, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (Estimate): August 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: March 26, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies; 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: 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