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

NCT01087203

Last updated date
Study Location
Pfizer Investigational Site
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 + 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 bipolar 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. Goodyear, Arizona
  3. Litchfield Park, Arizona
  4. Little Rock, Arkansas
  5. Fullerton, California
  6. Irvine, California
  7. La Jolla, California
  8. Boulder, Colorado
  9. Atlantis, Florida
  10. Bradenton, Florida
  11. Clearwater, Florida
  12. Destin, Florida
  13. Fort Walton Beach, Florida
  14. Hallandale Beach, Florida
  15. Palm Beach Gardens, Florida
  16. Sunrise, Florida
  17. West Palm Beach, Florida
  18. Decatur, Georgia
  19. Fort Wayne, Indiana
  20. Greenfield, Indiana
  21. Greenfirld, Indiana
  22. Lenexa, Kansas
  23. Hollywood, Maryland
  24. Ann Arbor, Michigan
  25. Nixa, Missouri
  26. Springfield, Missouri
  27. Missoula, Montana
  28. Asheville, North Carolina
  29. Dayton, Ohio
  30. Dayton, Ohio
  31. Toledo, Ohio
  32. Oklahoma City, Oklahoma
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  34. Greensburg, Pennsylvania
  35. Orangeburg, South Carolina
  36. Houston, Texas
  37. San Antonio, Texas
  38. San Antonio, Texas
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  24. Oklahoma City, Oklahoma
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  21. Greenville, North Carolina
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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 November 2010
Actual Primary Completion Date November 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 bipolar 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 and older   (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
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 August 2012

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