March 11, 2010
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March 16, 2010
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August 30, 2012
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March 2010
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November 2010 (Final data collection date for primary outcome measure)
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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 ]
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Same as current
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Complete list of historical versions of study NCT01087203 on ClinicalTrials.gov Archive Site
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- 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 ]
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- 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 ]
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Not Provided
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Not Provided
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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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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
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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.
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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.
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Interventional
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Phase 2
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
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Diabetic Peripheral Neuropathy
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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.
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Terminated
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73
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160
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November 2010
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November 2010 (Final data collection date for primary outcome measure)
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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.
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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United States
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Puerto Rico
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NCT01087203
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A4091031
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Yes
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Not Provided
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Not Provided
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Pfizer
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Pfizer
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Not Provided
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Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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Pfizer
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August 2012
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