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)

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215252
• Other study ID #: B3291026
• Secondary ID: DPN NAV1.7
• Status: Completed
• Phase: Phase 2
• First received: August 11, 2014
• Last updated: November 10, 2015
• Start date: November 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Peripheral Nervous System Diseases

Intervention

Drug:
• PF-05089771 150 mg
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
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
Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
• PF-05089771 150 mg + Pregabalin 300 mg
PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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