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

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ClinicalTrials.gov Identifier: NCT01087203
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : March 16, 2010
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Biological: Tanezumab Biological: placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tanezumab Biological: Tanezumab
20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
Other Name: PF-04383119
Placebo Comparator: Placebo Biological: placebo
Placebo to match tanezumab 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline to Week 16 in the average Diabetic Peripheral Neuropathy (DPN) pain as measured by an 11-point Numeric Rating Scale (NRS) for tanezumab vs. placebo treatment. [ Time Frame: Baseline, Wk 16 ]

Secondary Outcome Measures :
  1. Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12 in the average DPN pain NRS score derived from the patient daily diary. [ Time Frame: Baseline, Wks 2, 4, 6, 8 & 12 ]
  2. Cumulative distribution of percent change from Baseline in the average DPN pain NRS score to Week 16. [ Time Frame: Baseline & Wk 16 ]
  3. Response as defined by a ≥30%, ≥50%, ≥70% and a ≥90% reduction from Baseline in the average DPN pain NRS score derived from the patient daily diary at Weeks 1, 2, 4, 6, 8,12 and 16. [ Time Frame: Baseline, Wks 1, 2, 4, 6, 8, 12, & 16 ]
  4. Change from Baseline to Weeks 8 and 16 in the Brief Pain Inventory-short form (BPI-sf) scores. [ Time Frame: Baseline, Wks 8 & 16 ]
  5. Change from Baseline to Weeks 8 and 16 in the Neuropathic Pain Symptom Inventory (NPSI). [ Time Frame: Baseline, Wks 8 & 16 ]
  6. Change from Baseline to Weeks 4, 8, 12 and 16 in Patient's Global Assessment of Diabetic Peripheral Neuropathy. [ Time Frame: Baseline, Wks 8 & 16 ]
  7. Treatment Response: Improvement of ≥2 points in Patient's Global Assessment of Diabetic Peripheral Neuropathy at Weeks 4, 8, 12 and 16. [ Time Frame: Baseline, Wks 4, 8, 12 & 16 ]
  8. Change from Baseline to Week 16 in the EuroQol (EQ-5D) Health Questionnaire. [ Time Frame: Baseline & Wk 16 ]
  9. Time to discontinuation due to lack of efficacy. [ Time Frame: Time to discontinuation ]
  10. Usage of Rescue Medication. [ Time Frame: Wks 1, 2, 4, 6, 8, 12, & 16 ]
  11. Adverse events. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16 & 24 ]
  12. Safety laboratory testing (chemistry, hematology, urinalysis). [ Time Frame: Baseline, Wks 4, 8, 16, & 24 ]
  13. Single Electrocardiogram (ECG) 12-lead. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16, & 24 ]
  14. Physical examinations. [ Time Frame: Wks 16 & 24 ]
  15. Vital signs. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16 & 24 ]
  16. Anti drug antibody (ADA): serum samples collected predose on Day 1 (Baseline), predose at Week 8 (trough sample), Weeks 16 and 24 for assessment of immunogenicity. [ Time Frame: Baseline, Wks 8, 16 & 24 ]
  17. Neurological exam. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16 & 24 ]
  18. Change in the Neuropathy Symptoms and Change (NSC) score from Baseline to Week 16. [ Time Frame: Baseline & Wk 16 ]
  19. Change in Quantitative Sensory Testing (QST) in leg from Baseline to Week 16. [ Time Frame: Baseline & Wk 16 ]
  20. Change in density of nerve fibers in the leg from Baseline to Week 16. [ Time Frame: Baseline & Wk 16 ]
  21. Plasma tanezumab samples predose on Day 1 (Baseline), Weeks 2, 4, predose at Week 8 (trough sample), Weeks 12, 16 and 24 to characterize tanezumab pharmacokinetics in patients with DPN. [ Time Frame: Baseline, Wks 2, 4, 8, 12, 16 & 24 ]
  22. Serum nerve growth factor (NGF) samples predose on Day 1 Baseline), predose at Week 8 (trough sample), Weeks 16 and 24 for pharmacodynamic analysis. [ Time Frame: Baseline, Wks 8, 16, & 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087203


  Show 41 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01087203     History of Changes
Other Study ID Numbers: A4091031
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Pfizer:
diabetic peripheral neuropathy
tanezumab
diabetic neuropathies
diabetic polyneuropathy
diabetic neuropathy painful

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
 Endocrine System Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs