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Diabetic Neuropathy, PainfulPhase 2NCT02215252

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 Phase 2 study testing PF-05089771 150 mg, Pregabalin 300 mg and PF-05089771 150 mg + Pregabalin 300 mg in people with Diabetic Neuropathy, Painful, run by Pfizer at 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Neuropathy, Painful
What is being tested?
PF-05089771 150 mg, Pregabalin 300 mg and PF-05089771 150 mg + Pregabalin 300 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
141 participants
Where
32 sitesUnited States
Study dates
10 Nov 2014to 28 Sep 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Michigan Head Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • KRK Medical Research

    Arlington, Texas, 76012

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Meridien Research

    Bradenton, Florida, 34208

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Pulmonary Associates of Brandon (PAB)

    Brandon, Florida, 33511

  • Meridien Research

    Brooksville, Florida, 34601

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Clinical Research Advantage, Inc

    Evansville, Indiana, 47714

  • Clinical Physiology Associates

    Fort Myers, Florida, 33912

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • MD Clinical

    Hallandale, Florida, 33009

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030

  • New Phase Research and Development

    Knoxville, Tennessee, 37919

  • Meridien Research

    Lakeland, Florida, 33805

  • Clinical Research Consortium

    Las Vegas, Nevada, 89119

  • Novex Clinical Research, LLC

    New Bedford, Massachusetts, 02740

  • The Medical Research Network, LLC

    New York, New York, 10128

  • National Clinical Research - Norfolk, Inc

    Norfolk, Virginia, 23502

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23510

  • Family Care Specialists

    Ocala, Florida, 34471

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • Clinical Research Consortium Arizona

    Phoenix, Arizona, 85003

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Beacon Clinical Research, LLC

    Quincy, Massachusetts, 02169

  • Rainier Clinical Research Center, Inc

    Renton, Washington, 98057

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Meridien Research

    Tampa, Florida, 33634

  • Internal Medicine Associates

    Tullahoma, Tennessee, 37388

  • Trinity Clinical Research, LLC

    Tullahoma, Tennessee, 37388

  • Metabolic Research Institute, Inc

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: 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)

Being tested
PF-05089771 150 mg, Matched placebo for PF-05089771 150 mg and pregabalin 300 mg, Pregabalin 300 mg, PF-05089771 150 mg + Pregabalin 300 mg
Medical subject headings
Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-05089771 150 mgDrug

    PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.

  • Matched placebo for PF-05089771 150 mg and pregabalin 300 mgDrug

    Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.

  • Pregabalin 300 mgDrug

    Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.

  • PF-05089771 150 mg + Pregabalin 300 mgDrug

    PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.

Study groups in NCT02215252
Study groupRoleWhat they receive
PF-05089771ExperimentalNot described
Receives: Drug: PF-05089771 150 mg
PlaceboExperimentalNot described
Receives: Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
PregabalinExperimentalNot described
Receives: Drug: Pregabalin 300 mg
PF-05089771 + PregabalinExperimentalNot described
Receives: Drug: PF-05089771 150 mg + Pregabalin 300 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 1, Week 2, Week 3 and Week 4

Secondary outcomes (17)

  1. 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).

    Measured: Baseline, Week 1, Week 2, Week 3 and Week 4

  2. 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).

    Measured: Baseline, Week 1, Week 2, Week 3, and Week 4

  3. 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.

    Measured: Baseline, Week 2, and Week 4

  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.

    Measured: Baseline, Week 2 and Week 4

  5. 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.

    Measured: Baseline, Week 2, and Week 4

  6. 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.

    Measured: Baseline, Week 2 and Week 4

  7. 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.

    Measured: Baseline, Week 2 and Week 4

  8. 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.

    Measured: Baseline, Week 2 and Week 4

  9. 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".

    Measured: Baseline, Week 2, and Week 4

  10. 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.

    Measured: Baseline, Week 1, Week 2, Week 3 and Week 4

  11. Total Amount of Rescue Medication Per Week

    Total amount of rescue medication participants take per week

    Measured: Baseline, Week 1, Week 2, Week 3, and Week 4

  12. Number of Days Participants Take Rescue Medication

    Number of days participants take rescue medication per week.

    Measured: Baseline, Week 1, Week 2, Week 3 and Week 4

  13. 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.

    Measured: Screening to Day 36, and Day 64

  14. 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.

    Measured: Screening, Day 1, Day 15 and Day 29

  15. Fasted Total Cholesterol Values

    Percentage Change from Baseline in Fasted Total Cholesterol values

    Measured: Baseline, Week 2 and Week 4

  16. Fasted Low Density Lipoprotein (LDL) Cholesterol

    Percentage Change from Baseline in LDL cholesterol Friedewald by PEG

    Measured: Baseline, Week 2 and Week 4

  17. Plasma Concentration of PF-05089771

    All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.

    Measured: Baseline, Week 2 and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2014 (estimated)
  2. Study start10 Nov 2014
  3. Primary completion15 Jul 2015
  4. Study completion28 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02215252
Sponsor's protocol ID
B3291026
Other IDs
DPN NAV1.7
Status last verified
Mar 2017
First submitted
11 Aug 2014
Last updated
5 May 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-05089771 150 mg, Pregabalin 300 mg and PF-05089771 150 mg + Pregabalin 300 mg in people with Diabetic Neuropathy, Painful, run by Pfizer at 32 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Pain Numeric Rating Scale (NRS) (time frame: Baseline, Week 1, Week 2, Week 3 and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02215252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.

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