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

Primary Purpose

Diabetic Peripheral Neuropathy

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tanezumab

placebo

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring diabetic peripheral neuropathy, tanezumab, diabetic neuropathies, diabetic polyneuropathy, diabetic neuropathy painful

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 bipoar 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.

Sites / Locations

Alabama Orthopaedic Clinic
Coastal Clinical Research, Inc.
Dedicated Clinical Research
Valley Radiology, Ltd.
Dedicated Clinical Research
Clinical Trials, Inc.
Anaheim Hills MRI Holdings, Inc
Fullerton Neurology and Headache Center
NervePro Medical Corporation
United Medical Imaging Healthcare (X-Ray Only)
Coordinated Clinical Research
LabCorp (Draw blood only)
Alpine Clinical Research Center, Inc
JEM Research Institute
Medical Specialists of the Palm Beaches
Bradenton Research Center, Inc.
Innovative Research of West Florida, Inc.
SJS Clinical Research, Inc.
White Wilson Medical Center
MD Clinical
Laszlo J. Mate, MD
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Neurology Clinical Research, Inc.
Neurology Specialists of Decatur Research Center
Neurology Specialists of Decatur
Allied Physicians Inc d/b/a Fort Wayne Neurology
American Health Network of IN, LLC
Radiology Department, American Health Network
Lee Research Institute
Mid-Atlantic Medical Research Centers
Michigan Head Pain and Neurological Institute
Ozarks Community Hospital Christian County Clinic
Clinvest/A Division of Banyan Group, Inc.
Montana Neuroscience Institute Foundation
Asheville Neurology Specialists, PA
Joel Vandersluis, MD
Hometown Urgent Care and Research
Neurology and Neuroscience Center of Ohio
Lynn Health Science Institute
Mark A. Fisher M.D. -Private Practice
Westmoreland Neurology Associates, Inc
The Neurology and Pain Clinic
Centex Research/Pineloch Medical Center
Paragon Research Center, LLC
Innovative Clinical Trials
Daniel B. Vine, MD
Wasatch Clinical Research
RGL Medical Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tanezumab

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16

Participants assessed their DPN pain during the past 24 hours using 11-point Numeric Rating Scale (NRS) with score range of 0 (no pain) to 10 ( worst possible pain). Baseline score was calculated as the mean of the average pain scores over the 3 days in the initial pain assessment period. The Week 16 value was the average DPN Pain score calculated for the 7 days prior to and including Day 113 (Week 16).

Secondary Outcome Measures

Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12

Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain. Change: score at observation minus score at baseline.

Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16

Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain.

Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)

Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16

BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consists of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses are provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consists of 7 item subsets (A to G) which measure the level of interference of pain on daily functions. Responses are given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument is scored by item and by dimension, with lower scores indicating less pain or pain interference.

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)

Participant rated questionnaire to evaluate different symptoms of neuropathic pain (burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) during past 24-hour period and included 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.

Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16

BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses were provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consisted of 7 item subsets (A to G) as being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument was scored by item and by dimension, with lower scores indicated less pain or pain interference.

Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16

The PGA is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (very good: Asymptomatic and no limitation of normal activities) and a score of 5 being the worst (very poor: Very severe symptoms which are intolerable and inability to carry out all normal activities).

Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy

Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Scoring formula developed by Euro Quality of life group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.

Time to Discontinuation Due to Lack of Efficacy

Number of Participants Who Used Rescue Medication

Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Days Per Week of Rescue Medication Usage

Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Amount of Rescue Medication Taken

Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Number of Participants With Clinically Significant Laboratory Values

Criteria:Hemoglobin(Hgb),hematocrit,red blood cell(RBC)count:less than(<)0.8*lower limit of normal(LLN), mean cell Hgb,mean corpuscular volume,mean corpuscular Hgb concentration,mean platelet volume:<0.9*LLNor>1.1*upper limit of normal(ULN),platelet:<0.5*LLN >1.75* ULN, lymphocyte,neutrophil:<0.8*LLN or>1.2*ULN,basophil, eosinophil,monocyte:>1.2*ULN;bilirubin(total, direct,)>1.5*ULN, aspartate and alanine aminotransferase,alkaline phosphatase:> 3.0*ULN;gamma GT>3.0;cholestrol,triglycerides:>1.3*ULN; total protein, albumin:<0.8*LLN or>1.2*ULN ;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;sodium <0.95*LLNor>1.05*ULN,potassium,chloride,calcium,bicarbonate, magnesium:<0.9*LLN or >1.1*ULN;phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLNor>1.5*ULN,glycosylated Hgb>1.3*ULN,creatine kinase >2.0*ULN;urine(specific gravity<1.003or>1.030;pH <4.8or>8;glucose,ketone,proteins,blood/Hgb,bilirubin,nitrite>=1;WBC, RBC≥20/HPF;hyaline cast≥1;epithelial cell>=6;bacteria >1);serum pregnancy >=1.

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate (HR). Number of participants with clinically significant abnormal ECG findings reported as adverse events were presented.

Number of Participants With Clinically Significant Change From Baseline Physical Examination

Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat, lungs and thyroid.

Number of Participants With Clinically Significant Vital Signs Abnormalities

Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, pulse rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs reported as adverse events were presented.

Number of Participants With Anti Drug Antibody (ADA) for Tanezumab

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)

Neurologic examination assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes in order to complete the NIS. The NIS consists of 74 items (37 items assessed on the right side and 37 items assessed on the left side). Each item was rated on a scale of either 0 to 4 or 0 to 2 points, which were summed to calculate a total score. The NIS total score ranges from 0 to 244, where higher scores represent greater impairment.

Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)

The NSC (Neuropathy symptoms and change) is a standardized instrument and has been used to evaluate participants for number of symptoms of peripheral neuropathy. The NSC score included 38 (muscle weakness, Q1-19; sensation, Q20-29; and autonomic symptoms, Q30-38) symptom questions where the participants indicated experiencing the number of symptoms (to any severity). The score ranged from 0 to 38, with higher scores indicated more symptoms. The change score is the participant's comparison of the symptoms at last evaluation to the symptoms at onset. A change from baseline > 0 indicated increased neuropathy.

Change From Baseline in Quantitative Sensory Testing (QST) at Week 16

QST was performed on dorsum of foot and anterior thigh (at midpoint of a line from inguinal crease to midpoint of patella) to assess and quantify sensory function in lower extremity. Parameters were selected to assess small fiber function such as cooling detection threshold (mainly small diameter myelinated fibers, A delta), heat pain detection threshold (A delta and C fiber functions), and large fiber function via vibration detection threshold. normal deviate scores derived from a normal distribution of a reference population. A standard deviate score of 0 corresponds to 50th percentile of control population. Standard deviate score 1.96 corresponds to 95th percentile of normal distribution and -1.96 corresponds to 5th percentile of normal distribution. A normal deviate score indicated how many standard deviations higher (in case of positive normal deviate score) or lower (in case of negative normal deviate score) participant's value was relative to mean of reference population.

Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF

IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. IENF density was assessed from skin biopsies taken from the distal calves and distal thigh.

Plasma Tanezumab Concentration

Serum Nerve Growth Factor (NGF)

Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.

Full Information

NCT ID

NCT01087203

First Posted

March 11, 2010

Last Updated

February 22, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01087203

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

March 30, 2010 (Actual)

Primary Completion Date

November 18, 2010 (Actual)

Study Completion Date

July 6, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Peripheral Neuropathy

Keywords

diabetic peripheral neuropathy, tanezumab, diabetic neuropathies, diabetic polyneuropathy, diabetic neuropathy painful

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tanezumab

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Tanezumab

Other Intervention Name(s)

PF-04383119

Intervention Description

20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

Placebo to match tanezumab 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)

Primary Outcome Measure Information:

Title

Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16

Description

Time Frame

Baseline, Week 16

Secondary Outcome Measure Information:

Title

Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12

Description

Time Frame

Baseline, Week 1, 2, 4, 6, 8, 12

Title

Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16

Description

Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain.

Time Frame

Week 16

Title

Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)

Description

Time Frame

Week 1, 2, 4, 6, 8, 12, 16

Title

Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16

Description

Time Frame

Baseline, Week 8, 16

Title

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)

Description

Time Frame

Baseline, Week 8, 16

Title

Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16

Description

BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses were provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consisted of 7 item subsets (A to G) as being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument was scored by item and by dimension, with lower scores indicated less pain or pain interference.

Time Frame

Baseline, Week 8, 16

Title

Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16

Description

Time Frame

Baseline, Week 4, 8, 12, 16

Title

Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy

Description

Time Frame

Week 4, 8, 12, 16

Title

Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16

Description

Time Frame

Baseline, Week 16

Title

Time to Discontinuation Due to Lack of Efficacy

Time Frame

Baseline up to Week 16

Title

Number of Participants Who Used Rescue Medication

Description

Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Time Frame

Week 1, 2, 4, 6, 8, 12, 16

Title

Days Per Week of Rescue Medication Usage

Description

Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Time Frame

Week 1, 2, 4, 6, 8, 12, 16

Title

Amount of Rescue Medication Taken

Description

Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Time Frame

Week 1, 2, 4, 6, 8, 12, 16

Title

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Baseline up to 112 days after last dose of study treatment (up to 169 days)

Title

Number of Participants With Clinically Significant Laboratory Values

Description

Time Frame

Baseline up to Week 24

Title

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

Description

Time Frame

Baseline up to Week 24

Title

Number of Participants With Clinically Significant Change From Baseline Physical Examination

Description

Time Frame

Baseline up to Week 24

Title

Number of Participants With Clinically Significant Vital Signs Abnormalities

Description

Time Frame

Baseline up to Week 24

Title

Number of Participants With Anti Drug Antibody (ADA) for Tanezumab

Description

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).

Time Frame

Baseline, Week 8, 16, 24

Title

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16 and 24

Title

Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Quantitative Sensory Testing (QST) at Week 16

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF

Description

Time Frame

Baseline, Week 16

Title

Plasma Tanezumab Concentration

Time Frame

Baseline(Day 1), Week 2, 4, 8, 12, 16, 24

Title

Serum Nerve Growth Factor (NGF)

Description

Time Frame

Day 1, Week 8, 16, 24

Other Pre-specified Outcome Measures:

Title

Number of Participants With Subcutaneous Doses of Study Medication

Description

Number of participants are reported based on the maximum number of Subcutaneous doses of either tanezumab or placebo received.

Time Frame

Day 1 up to Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility 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 bipoar 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Alabama Orthopaedic Clinic

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Coastal Clinical Research, Inc.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Dedicated Clinical Research

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85395

Country

United States

Facility Name

Valley Radiology, Ltd.

City

Goodyear

State/Province

Arizona

ZIP/Postal Code

85395

Country

United States

Facility Name

Dedicated Clinical Research

City

Litchfield Park

State/Province

Arizona

ZIP/Postal Code

85340

Country

United States

Facility Name

Clinical Trials, Inc.

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Anaheim Hills MRI Holdings, Inc

City

Anaheim Hills

State/Province

California

ZIP/Postal Code

92807

Country

United States

Facility Name

Fullerton Neurology and Headache Center

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

NervePro Medical Corporation

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Facility Name

United Medical Imaging Healthcare (X-Ray Only)

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Facility Name

Coordinated Clinical Research

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

LabCorp (Draw blood only)

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Alpine Clinical Research Center, Inc

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

JEM Research Institute

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Medical Specialists of the Palm Beaches

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Bradenton Research Center, Inc.

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Facility Name

Innovative Research of West Florida, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

SJS Clinical Research, Inc.

City

Destin

State/Province

Florida

ZIP/Postal Code

32541

Country

United States

Facility Name

White Wilson Medical Center

City

Fort Walton Beach

State/Province

Florida

ZIP/Postal Code

32547

Country

United States

Facility Name

MD Clinical

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Facility Name

Laszlo J. Mate, MD

City

North Palm Beach

State/Province

Florida

ZIP/Postal Code

33408

Country

United States

Facility Name

Palm Beach Neurological Center, Advanced Research Consultants, Inc.

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33418

Country

United States

Facility Name

Neurology Clinical Research, Inc.

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

Neurology Specialists of Decatur Research Center

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Neurology Specialists of Decatur

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Allied Physicians Inc d/b/a Fort Wayne Neurology

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46805

Country

United States

Facility Name

American Health Network of IN, LLC

City

Greenfield

State/Province

Indiana

ZIP/Postal Code

46140-2834

Country

United States

Facility Name

Radiology Department, American Health Network

City

Greenfield

State/Province

Indiana

ZIP/Postal Code

46140-2834

Country

United States

Facility Name

Lee Research Institute

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Mid-Atlantic Medical Research Centers

City

Hollywood

State/Province

Maryland

ZIP/Postal Code

20636

Country

United States

Facility Name

Michigan Head Pain and Neurological Institute

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

Ozarks Community Hospital Christian County Clinic

City

Nixa

State/Province

Missouri

ZIP/Postal Code

65714

Country

United States

Facility Name

Clinvest/A Division of Banyan Group, Inc.

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Montana Neuroscience Institute Foundation

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

Facility Name

Asheville Neurology Specialists, PA

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28806

Country

United States

Facility Name

Joel Vandersluis, MD

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Hometown Urgent Care and Research

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45432

Country

United States

Facility Name

Neurology and Neuroscience Center of Ohio

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43623

Country

United States

Facility Name

Lynn Health Science Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Mark A. Fisher M.D. -Private Practice

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Westmoreland Neurology Associates, Inc

City

Greensburg

State/Province

Pennsylvania

ZIP/Postal Code

15601-2234

Country

United States

Facility Name

The Neurology and Pain Clinic

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Centex Research/Pineloch Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77062

Country

United States

Facility Name

Paragon Research Center, LLC

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

Facility Name

Innovative Clinical Trials

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Daniel B. Vine, MD

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Wasatch Clinical Research

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

RGL Medical Services

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84084

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

25594611

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091031&StudyName=A%20Study%20Of%20The%20Analgesic%20%28Pain-Relief%29%20Effects%20Of%20Tanezumab%20In%20Adult%20Patients%20With%20Diabetic%20Peripheral%20Neuropathy%20

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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