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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

Tracking Information
First Submitted Date  ICMJE March 11, 2010
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date August 30, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01087203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2010)
  • 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 ]
  • Cumulative distribution of percent change from Baseline in the average DPN pain NRS score to Week 16. [ Time Frame: Baseline & Wk 16 ]
  • 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 ]
  • Change from Baseline to Weeks 8 and 16 in the Brief Pain Inventory-short form (BPI-sf) scores. [ Time Frame: Baseline, Wks 8 & 16 ]
  • Change from Baseline to Weeks 8 and 16 in the Neuropathic Pain Symptom Inventory (NPSI). [ Time Frame: Baseline, Wks 8 & 16 ]
  • 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 ]
  • 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 ]
  • Change from Baseline to Week 16 in the EuroQol (EQ-5D) Health Questionnaire. [ Time Frame: Baseline & Wk 16 ]
  • Time to discontinuation due to lack of efficacy. [ Time Frame: Time to discontinuation ]
  • Usage of Rescue Medication. [ Time Frame: Wks 1, 2, 4, 6, 8, 12, & 16 ]
  • Adverse events. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16 & 24 ]
  • Safety laboratory testing (chemistry, hematology, urinalysis). [ Time Frame: Baseline, Wks 4, 8, 16, & 24 ]
  • Single Electrocardiogram (ECG) 12-lead. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16, & 24 ]
  • Physical examinations. [ Time Frame: Wks 16 & 24 ]
  • Vital signs. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16 & 24 ]
  • 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 ]
  • Neurological exam. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16 & 24 ]
  • Change in the Neuropathy Symptoms and Change (NSC) score from Baseline to Week 16. [ Time Frame: Baseline & Wk 16 ]
  • Change in Quantitative Sensory Testing (QST) in leg from Baseline to Week 16. [ Time Frame: Baseline & Wk 16 ]
  • Change in density of nerve fibers in the leg from Baseline to Week 16. [ Time Frame: Baseline & Wk 16 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2010)
  • 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 ]
  • Cumulative distribution of percent change from Baseline in the average DPN pain NRS score to Week 16. [ Time Frame: Baseline & Wk 16 ]
  • 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 ]
  • Change from Baseline to Weeks 8 and 16 in the Brief Pain Inventory-short form (BPI-sf) scores. [ Time Frame: Baseline, Wks 8 & 16 ]
  • Change from Baseline to Weeks 8 and 16 in the Neuropathic Pain Symptom Inventory (NPSI). [ Time Frame: Baseline, Wks 8 & 16 ]
  • 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 ]
  • 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 ]
  • Change from Baseline to Week 16 in the EuroQol (EQ-5D) Health Questionnaire. [ Time Frame: Baseline & Wk 16 ]
  • Time to discontinuation due to lack of efficacy.
  • Usage of Rescue Medication. [ Time Frame: Wks 1, 2, 4, 6, 8, 12, & 16 ]
  • Adverse events. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16 & 24 ]
  • Safety laboratory testing (chemistry, hematology, urinalysis). [ Time Frame: Baseline, Wks 4, 8, 16, & 24 ]
  • Single Electrocardiogram (ECG) 12-lead. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16, & 24 ]
  • Physical examinations. [ Time Frame: Wks 16 & 24 ]
  • Vital signs. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16 & 24 ]
  • 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 ]
  • Neurological exam. [ Time Frame: Baseline, Wks 2, 4, 6, 8, 12, 16 & 24 ]
  • Change in the Neuropathy Symptoms and Change (NSC) score from Baseline to Week 16. [ Time Frame: Baseline & Wk 16 ]
  • Change in Quantitative Sensory Testing (QST) in leg from Baseline to Week 16. [ Time Frame: Baseline & Wk 16 ]
  • Change in density of nerve fibers in the leg from Baseline to Week 16. [ Time Frame: Baseline & Wk 16 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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