A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy

NCT01087203

Last updated date
Study Location
Alabama Orthopaedic Clinic
Mobile, Alabama, 36608, 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.
Diabetic Peripheral Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ≤11% at Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to randomization.

- Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk/ reflexes.

- Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months.

- A pain score of greater than or equal to (≥) 4 for from diabetic peripheral neuropathy on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10 meaning worst pain at Screening.

- Be willing to stop all pain medications for diabetic peripheral neuropathy except for the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications between Screening and Baseline and not use prohibited pain medications throughout the duration of the study except as permitted by the study guidelines.

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


- Painful neuropathies other than diabetic peripheral neuropathy.


- Other types of diabetic neuropathies.


- Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of
CTS in the one year prior to Screening are not eligible for participation.


- Patients with fibromyalgia, regional pain caused by lumbar or cervical compression
with radiculopathy or other moderate to severe pain.


- Patients with a present (current) history of sciatica are not eligible for
participation.


- The presence of pain conditions that cannot be distinguished from diabetic peripheral
neuropathy such as peripheral vascular disease.


- Amputations dues to diabetes.


- Patient with any clinically significant medical condition or laboratory abnormalities.


- History, diagnosis, or signs and symptoms of clinically significant neurological
diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke).


- History, diagnosis, or signs and symptoms of clinically significant psychiatric
diseases (such as bipoar disorder or schizophrenia).


- History of known alcohol, analgesic or drug abuse within 2 years of Screening.


- Pregnant women, lactating mothers, women suspected of being pregnant, and women who
wish to be pregnant during the course of clinical study.

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Diabetic Peripheral NeuropathyA Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
NCT01087203
  1. Mobile, Alabama
  2. Mobile, Alabama
  3. Goodyear, Arizona
  4. Goodyear, Arizona
  5. Litchfield Park, Arizona
  6. Little Rock, Arkansas
  7. Anaheim Hills, California
  8. Fullerton, California
  9. Irvine, California
  10. Irvine, California
  11. La Jolla, California
  12. La Jolla, California
  13. Boulder, Colorado
  14. Atlantis, Florida
  15. Atlantis, Florida
  16. Bradenton, Florida
  17. Clearwater, Florida
  18. Destin, Florida
  19. Fort Walton Beach, Florida
  20. Hallandale Beach, Florida
  21. North Palm Beach, Florida
  22. Palm Beach Gardens, Florida
  23. Sunrise, Florida
  24. Decatur, Georgia
  25. Decatur, Georgia
  26. Fort Wayne, Indiana
  27. Greenfield, Indiana
  28. Greenfield, Indiana
  29. Lenexa, Kansas
  30. Hollywood, Maryland
  31. Ann Arbor, Michigan
  32. Nixa, Missouri
  33. Springfield, Missouri
  34. Missoula, Montana
  35. Asheville, North Carolina
  36. Dayton, Ohio
  37. Dayton, Ohio
  38. Toledo, Ohio
  39. Oklahoma City, Oklahoma
  40. Oklahoma City, Oklahoma
  41. Greensburg, Pennsylvania
  42. Orangeburg, South Carolina
  43. Houston, Texas
  44. San Antonio, Texas
  45. San Antonio, Texas
  46. Salt Lake City, Utah
  47. Salt Lake City, Utah
  48. West Jordan, Utah
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  9. Clearwater, Florida
  10. North Palm Beach, Florida
  11. Tampa, Florida
  12. West Palm Beach, Florida
  13. Winter Haven, Florida
  14. Columbus, Georgia
  15. Evansville, Indiana
  16. Wichita, Kansas
  17. Omaha, Nebraska
  18. Henderson, Nevada
  19. Las Vegas, Nevada
  20. Las Vegas, Nevada
  21. New York, New York
  22. Toledo, Ohio
  23. Oklahoma City, Oklahoma
  24. Oklahoma City, Oklahoma
  25. Medford, Oregon
  26. Portland, Oregon
  27. Portland, Oregon
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  29. Duncansville, Pennsylvania
  30. Pawtucket, Rhode Island
  31. Orangeburg, South Carolina
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  33. Houston, Texas
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Diabetic Peripheral NeuropathySafety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy
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  5. Denver, Colorado
  6. Ocala, Florida
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  8. Palm Beach Gardens, Florida
  9. Sunrise, Florida
  10. West Palm Beach, Florida
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  12. Boston, Massachusetts
  13. Omaha, Nebraska
  14. Omaha, Nebraska
  15. Las Vegas, Nevada
  16. Englewood, New Jersey
  17. New Brunswick, New Jersey
  18. Albany, New York
  19. Rochester, New York
  20. Rochester, New York
  21. Greenville, North Carolina
  22. Toledo, Ohio
  23. Duncansville, Pennsylvania
  24. Dallas, Texas
  25. Dallas, Texas
  26. Houston, Texas
  27. San Antonio, Texas
  28. Salt Lake City, Utah
  29. Salt Lake City, Utah
ALL GENDERS
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
Official Title  ICMJE A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY
Brief Summary The purpose of this study is to determine the effectiveness and safety of the investigational drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.
Detailed Description This study was terminated on 18 November 2010 following a US FDA clinical hold for the tanezumab diabetic peripheral neuropathy clinical study which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.
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 Peripheral Neuropathy
Intervention  ICMJE
  • Biological: Tanezumab
    20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
    Other Name: PF-04383119
  • Biological: placebo
    Placebo to match tanezumab 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
Study Arms  ICMJE
  • Experimental: Tanezumab
    Intervention: Biological: Tanezumab
  • Placebo Comparator: Placebo
    Intervention: Biological: placebo
Publications * Bramson C, Herrmann DN, Carey W, Keller D, Brown MT, West CR, Verburg KM, Dyck PJ. Exploring the role of tanezumab as a novel treatment for the relief of neuropathic pain. Pain Med. 2015 Jun;16(6):1163-76. doi: 10.1111/pme.12677. Epub 2015 Jan 16.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: August 23, 2012)
73
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2010)
160
Actual Study Completion Date  ICMJE July 6, 2011
Actual Primary Completion Date November 18, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ?11% at Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to randomization.
  • Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk/ reflexes.
  • Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months.
  • A pain score of greater than or equal to (?) 4 for from diabetic peripheral neuropathy on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10 meaning worst pain at Screening.
  • Be willing to stop all pain medications for diabetic peripheral neuropathy except for the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications between Screening and Baseline and not use prohibited pain medications throughout the duration of the study except as permitted by the study guidelines.

Exclusion Criteria:

  • Painful neuropathies other than diabetic peripheral neuropathy.
  • Other types of diabetic neuropathies.
  • Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening are not eligible for participation.
  • Patients with fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain.
  • Patients with a present (current) history of sciatica are not eligible for participation.
  • The presence of pain conditions that cannot be distinguished from diabetic peripheral neuropathy such as peripheral vascular disease.
  • Amputations dues to diabetes.
  • Patient with any clinically significant medical condition or laboratory abnormalities.
  • History, diagnosis, or signs and symptoms of clinically significant neurological diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke).
  • History, diagnosis, or signs and symptoms of clinically significant psychiatric diseases (such as bipoar disorder or schizophrenia).
  • History of known alcohol, analgesic or drug abuse within 2 years of Screening.
  • Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 99 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 Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT01087203
Other Study ID Numbers  ICMJE A4091031
DPN PHASE 2B ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/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 February 2021

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