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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)

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Clinical Research Consortium Arizona
Phoenix, Arizona, 85003 United States
Contact
1-800-718-1021
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.

NCT02215252
Pfizer
Completed
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)

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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)
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
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)
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetic Neuropathy, Painful
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
September 28, 2015
July 15, 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02215252
B3291026
DPN NAV1.7 ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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/da...

Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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