Clinical trial 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuropathy, Painful
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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.

Primary outcomes:
measure: Daily Pain Numeric Rating Scale (NRS)
timeFrame: Baseline, Week 1, Week 2, Week 3 and Week 4
Secondary outcomes:
measure: Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score
timeFrame: Baseline, Week 1, Week 2, Week 3 and Week 4
measure: Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
measure: Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain
timeFrame: Baseline, Week 2, and Week 4
measure: Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain
timeFrame: Baseline, Week 2 and Week 4
measure: Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain
timeFrame: Baseline, Week 2, and Week 4
measure: Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain
timeFrame: Baseline, Week 2 and Week 4
measure: Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia
timeFrame: Baseline, Week 2 and Week 4
measure: Neuropathic Pain Symptom Inventory (NPSI) - Total Score
timeFrame: Baseline, Week 2 and Week 4
measure: Patient's Global Impression of Change Score (PGIC).
timeFrame: Baseline, Week 2, and Week 4
measure: Daily Sleep Interference Scale Score (DSIS).
timeFrame: Baseline, Week 1, Week 2, Week 3 and Week 4
measure: Total Amount of Rescue Medication Per Week
timeFrame: Baseline, Week 1, Week 2, Week 3, and Week 4
measure: Number of Days Participants Take Rescue Medication
timeFrame: Baseline, Week 1, Week 2, Week 3 and Week 4
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)
timeFrame: Screening to Day 36, and Day 64
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: Screening, Day 1, Day 15 and Day 29
measure: Fasted Total Cholesterol Values
timeFrame: Baseline, Week 2 and Week 4
measure: Fasted Low Density Lipoprotein (LDL) Cholesterol
timeFrame: Baseline, Week 2 and Week 4
measure: Plasma Concentration of PF-05089771
timeFrame: Baseline, Week 2 and Week 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Clinical Research Consortium Arizona
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Brandon
country: United States
facility: Pulmonary Associates of Brandon (PAB)
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Fort Myers
country: United States
facility: Clinical Physiology Associates
state: Florida
city: Hallandale
country: United States
facility: MD Clinical
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Ocala
country: United States
facility: Family Care Specialists
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research, LLC
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Evansville
country: United States
facility: Clinical Research Advantage, Inc
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New Bedford
country: United States
facility: Novex Clinical Research, LLC
state: Massachusetts
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Tullahoma
country: United States
facility: Internal Medicine Associates
state: Tennessee
city: Tullahoma
country: United States
facility: Trinity Clinical Research, LLC
state: Tennessee
city: Arlington
country: United States
facility: KRK Medical Research
state: Texas
city: Houston
country: United States
facility: Nerve and Muscle Center of Texas
state: Texas
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: