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)

Pfizer141 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

141

Conditions

Diabetic Neuropathy, Painful

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (32)

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 1, Week 2, Week 3 and Week 4

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Clinical Research Consortium Arizona

Phoenix, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Neuro-Pain Medical Center

Fresno, California, United States

Meridien Research

Bradenton, Florida, United States

PAB Clinical Research

Brandon, Florida, United States

Pulmonary Associates of Brandon (PAB)

Brandon, Florida, United States

Meridien Research

Brooksville, Florida, United States

Clinical Physiology Associates

Fort Myers, Florida, United States

MD Clinical

Hallandale, Florida, United States

Meridien Research

Lakeland, Florida, United States

...and 22 more locations

Time frame: Baseline, Week 2 and Week 4

Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain

Time frame: Baseline, Week 2, and Week 4

Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain

Time frame: Baseline, Week 2 and Week 4

Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia

Time frame: Baseline, Week 2 and Week 4

Neuropathic Pain Symptom Inventory (NPSI) - Total Score

Time frame: 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".

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Screening, Day 1, Day 15 and Day 29

Fasted Total Cholesterol Values

Percentage Change from Baseline in Fasted Total Cholesterol values

Time frame: Baseline, Week 2 and Week 4

Fasted Low Density Lipoprotein (LDL) Cholesterol

Percentage Change from Baseline in LDL cholesterol Friedewald by PEG

Time frame: 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.

Time frame: Baseline, Week 2 and Week 4