Diabetic Neuropathy, Painful Clinical Trial
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
Verified date | November 2015 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 141 |
Est. completion date | September 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
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 | Columbus Regional Research Institute | Columbus | Georgia |
United States | KRK Medical Research | Dallas | Texas |
United States | Clinical Research Advantage, Inc | Evansville | Indiana |
United States | Clinical Physiology Associates | Fort Myers | Florida |
United States | Neuro-Pain Medical Center | Fresno | California |
United States | MD Clinical | Hallandale | Florida |
United States | Nerve and Muscle Center of Texas | Houston | Texas |
United States | New Phase Research and Development | Knoxville | Tennessee |
United States | Meridien Research | Lakeland | Florida |
United States | Clinical Research Consortium | Las Vegas | Nevada |
United States | Novex Clinical Research, LLC | New Bedford | Massachusetts |
United States | The Medical Research Network, LLC | New York | New York |
United States | Eastern Virginia Medical School | Norfolk | Virginia |
United States | National Clinical Research - Norfolk, Inc | Norfolk | Virginia |
United States | Family Care Specialists | Ocala | Florida |
United States | Renstar Medical Research | Ocala | Florida |
United States | Compass Research East Llc | Oviedo | Florida |
United States | Arizona Research Center | Phoenix | Arizona |
United States | Clinical Research Consortium Arizona | Phoenix | Arizona |
United States | Beacon Clinical Research, LLC | Quincy | Massachusetts |
United States | Rainier Clinical Research Center, Inc | Renton | Washington |
United States | Meridien Research | St. Petersburg | Florida |
United States | Meridien Research | Tampa | Florida |
United States | Internal Medicine Associates | Tullahoma | Tennessee |
United States | Trinity Clinical Research, LLC | Tullahoma | Tennessee |
United States | Metabolic Research Institute, Inc | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily Pain Rating Scale (DPRS) | DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | Average of the last 7 days' pain numerical rating scores in week 4 of the treatment period. | No |
Secondary | Neuropathic Pain Symptom Inventory (NPSI) | NPSI: 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]). Includes 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. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. | Day -7, Day 1, 15, 29 and 36 | No |
Secondary | Patient Global Impression of Change (PGI-C) | PGI-C: 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). | Day 1, 15, 29 and 36 | No |
Secondary | Daily Sleep Interference Scale (DSIS) | 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. | Day-7, daily through to Day 36 | No |
Secondary | Responder rate | Based on a 30% and 50% improvement in mean pain response using the daily pain NRS score. | Day 1, Day 29 | No |
Secondary | Rescue Medication use | Number of days subjects take rescue medication and amount of rescue medication used. | Day 1, Day 29 | No |
Secondary | Low Density Lipoprotein (LDL) and Total Cholesterol values | Collection of fasted blood samples for LDL and total cholesterol measurement | Day 1, Day 15, Day 29 | No |
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