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

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

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, Senior)
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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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. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01087203 History of Changes
Other Study ID Numbers:	A4091031
First Posted:	March 16, 2010
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