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Completed

NCT Number: NCT02215252

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)

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)

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Key information

Conditions

Diabetic Neuropathy, Painful Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Research Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-05089771 150 mg

Drug

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

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

Drug

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 mg

Drug

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

PF-05089771 150 mg + Pregabalin 300 mg

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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".

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. Fasted Total Cholesterol Values

    Time frame: Baseline, Week 2 and Week 4

    Percentage Change from Baseline in Fasted Total Cholesterol values

  16. Fasted Low Density Lipoprotein (LDL) Cholesterol

    Time frame: Baseline, Week 2 and Week 4

    Percentage Change from Baseline in LDL cholesterol Friedewald by PEG

  17. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2014
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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