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)

Back to Search
Print
Bookmark Trial

NCT02215252

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Clinical Research Consortium Arizona
Phoenix, Arizona, 85003, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Painful Diabetic NeuropathyA Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
NCT00553280
  1. Nagoya, Aichi
  2. Date-shi, Fukushima
  3. Nihonmatsu, Fukushima
  4. Shirakawa-shi, Fukushima
  5. Sukagawa, Fukushima
  6. Kamakura, Kanagawa
  7. Yokohama, Kanagawa
  8. Sendai, Miyagi
  9. Matsumoto, Nagano
  10. Ueda, Nagano
  11. Beppu, Oita
  12. Yamada, Okayama
  13. Naha, Okinawa
  14. Tomishiro, Okinawa
  15. Urazoe, Okinawa
  16. Hirano-ku, Osaka
  17. Suminoe-ku, Osaka
  18. Sunto-gun, Shizuoka
  19. Oyama-shi, Tochigi
  20. Arakawa, Tokyo
  21. Bunkyo-ku, Tokyo
  22. Chiyoda-ku, Tokyo
  23. Ohta-ku, Tokyo
  24. Shibuya-ku, Tokyo
  25. Fukuoka,
  26. Oita,
  27. Tokushima,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Painful Diabetic NeuropathyRandomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
NCT00553475
  1. Nagoya, Aichi
  2. Chikushino, Fukuoka
  3. Kasuga, Fukuoka
  4. Date-shi, Fukushima
  5. Nihonmatsu, Fukushima
  6. Shirakawa-shi, Fukushima
  7. Sukagawa, Fukushima
  8. Kure, Hiroshima
  9. Chitose, Hokkaido
  10. Ebetu, Hokkaido
  11. Sapporo, Hokkaido
  12. Sapporo, Hokkaiido
  13. Kobe, Hyogo
  14. Inashiki, Ibaraki
  15. Kamakura, Kanagawa
  16. Yokohama, Kanagawa
  17. Yatsushiro, Kumamoto
  18. Sendai, Miyagi
  19. Matsumoto, Nagano
  20. Ueda, Nagano
  21. Beppu, Oita
  22. Yamada, Okayama
  23. Naha, Okinawa
  24. Tomishiro, Okinawa
  25. Urazoe, Okinawa
  26. Higashiosaka, Osaka
  27. Hirano-ku, Osaka
  28. Kishiwada, Osaka
  29. Suminoe-ku, Osaka
  30. Sunto-gun, Shizuoka
  31. Oyama-shi, Tochigi
  32. Utsunomiya, Tochigi
  33. Arakawa, Tokyo
  34. Bunkyo-ku, Tokyo
  35. Chiyoda-ku, Tokyo
  36. Chuo-ku, Tokyo
  37. Minato-ku, Tokyo
  38. Nishitokyo, Tokyo
  39. Ohta-ku, Tokyo
  40. Shibuya-ku, Tokyo
  41. Fukuoka,
  42. Kumamoto,
  43. Nagasaki,
  44. Niigata,
  45. Oita,
  46. Okayama,
  47. Saga,
  48. Saitama,
  49. Tokushima,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Painful Diabetic NeuropathyStudy Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
NCT01050218
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Painful Diabetic NeuropathyA Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
NCT00156078
  1. Buenos Aires,
  2. Belo Horizonte, MG
  3. Niteroi, RJ
  4. Providencia, Santiago
  5. Valparaiso, V Region
  6. Medellin, Antioquia
  7. Bogotá, Cundinamarca
  8. Quito, Pichincha
  9. Jakarta Pusat,
  10. Surabaya,
  11. Amman,
  12. Pusan,
  13. Seoul,
  14. Beirut,
  15. Kuala Lumpur,
  16. Monterrey, Nuevo Leon
  17. Mexico Df,
  18. San Luis Potosi,
  19. Espana, Manila
  20. Quezon City,
  21. Riyadh,
  22. Singapore,
  23. Gueishan Shiang, Taoyan Hsien
  24. Taipei,
  25. Khet Rajathevee, Bangkok
  26. Muang, Chiang Mai
  27. Capa, Istanbul
  28. Ankara,
  29. Istanbul,
  30. Izmir,
  31. Mersin,
  32. Abu Dhabi,
  33. El Hatillo, Caracas-Estado Miranda
  34. Caracas, Distrito Capital
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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