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)

NCT02215252

Last updated date
Study Location
Clinical Research Consortium Arizona
Phoenix, Arizona, 85003, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Painful Diabetic Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy, Painful
Intervention  ICMJE
  • Drug: PF-05089771 150 mg
    PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
  • Drug: 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.
  • Drug: Pregabalin 300 mg
    Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: PF-05089771
    Intervention: Drug: PF-05089771 150 mg
  • Experimental: Placebo
    Intervention: Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
  • Experimental: Pregabalin
    Intervention: Drug: Pregabalin 300 mg
  • Experimental: PF-05089771 + Pregabalin
    Intervention: Drug: PF-05089771 150 mg + Pregabalin 300 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2015)
141
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2014)
458
Actual Study Completion Date  ICMJE September 28, 2015
Actual Primary Completion Date July 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02215252
Other Study ID Numbers  ICMJE B3291026
DPN NAV1.7 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/d…

Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP