RN624 For Pain Of Post-Herpetic Neuralgia

A PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH POST-HERPETIC NEURALGIA

This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).

Study Overview

• Status: Completed
• Conditions: Neuralgia, Postherpetic
• Intervention / Treatment: Drug: Placebo; Drug: RN624; Drug: RN624

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Anniston Medical Clinic/Pinnacle Research Group LLC
    • Anniston, Alabama, United States, 36207
      • Anniston Neurology & Headache Mgmt. Ctr.
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Dedicated Clinical Research, Inc.
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research, LLC
    • Clearwater, Florida, United States, 33765
      • Clinical Research of West Florida
    • Largo, Florida, United States, 33770
      • Innovative Research Of West Florida, Inc.
    • Miami, Florida, United States, 33175
      • Miami Medical Associates
    • Palm Beach Gardens, Florida, United States, 33418
      • Palm Beach Neurological Center, Advanced Research Consultants, Inc.
    • Sunrise, Florida, United States, 33351
      • Neurology Clinical Research, Inc.
    • Tampa, Florida, United States, 33606
      • Meridien Research
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinic
  • Maryland
    • Towson, Maryland, United States, 21286
      • International Research Center
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Infinity Medical Research, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain and Neurological Institute
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Medical Advanced Pain Specialists (MAPS)
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • A & A Pain Institute
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Asheville Neurology Specialists, PA
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research, Inc.
    • Dayton, Ohio, United States, 45432
      • Hometown Urgent Care and Research
    • Kettering, Ohio, United States, 45429
      • Wells Institute for Health Awareness
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Allegheny Pain Management, PC
    • Duncansville, Pennsylvania, United States, 16635-0909
      • Altoona Center for Clinical Research
  • Texas
    • Bryan, Texas, United States, 77802
      • DiscoveResearch Incorporated
    • Dallas, Texas, United States, 75230
      • Neurological Clinic of Texas
    • Houston, Texas, United States, 77024
      • Mobley Research Center
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78229
      • Jay Ellis Jr., MD-Tejas Anesthesia
    • San Antonio, Texas, United States, 78229
      • Radiant Research San Antonio Northeast
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research, Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female of any race, at least 18 years of age.
• Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash.
• Has a pain score at screening that qualifies.
• Completes at least 3 average daily pain diaries during the 3 days prior to randomization and has an average pain level that qualifies.
• Body Mass Index less than or equal to 39 kg/m2.
• If female, is post-menopausal, surgically sterile, or uses adequate contraception consisting of 2 forms of birth control, one of which must be barrier method, is not lactating, and is not breastfeeding.
• Male patients must agree that female spouses/partners will use contraception as defined above or be of nonchildbearing potential (post-menopausal or surgically sterile).
• Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Patients must consent in writing to participate in the study.

Exclusion Criteria:

• Patients who cannot discontinue the use of other pain medications during the screening period and during the study.
• Disqualifying scores on questionnaires.
• Other moderate to severe pain from other conditions.
• History of allergic or anaphylactic reaction to antibodies.
• Use of biologics, including any live vaccines within 3 months of the week prior to the baseline visit.
• Unable to use acetaminophen.
• Disqualify laboratory values, Hepatitis B or C or HIV.
• Patients that have had a stroke or TIAs, dementia, epilepsy or seizures, or peripheral neuropathy from other conditions.
• Significant cardiac disease within 3 months of the study such as angina, heart attack, congestive heart failure, and other cardiac problems.
• Cancer other than basal cell or squamous cell carcinoma.
• Fails a urine test for illegal drugs including prescription drugs without a prescription.
• Plans for surgery during the study.
• History of alcoholism or drug abuse in the past two years.
• Surgery for post-herpetic neuralgia.
• Any condition that the investigator feels would put the safety of the patient at risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: RN624; 50 mcg/kg; Drug: RN624; 200 mcg/kg
Active Comparator: 2	Drug: RN624; 50 mcg/kg; Drug: RN624; 200 mcg/kg
Placebo Comparator: 3	Drug: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6	Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.	Baseline, Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16	Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post Baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days prior to corresponding week visits. The change from baseline was calculated using difference between post baseline weekly mean score and the Baseline mean score.	Baseline, Week 1, 2, 4, 8, 12, 16
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16	Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Scores for each time interval over the weeks were calculated from the mean of daily pain score of participants over that specified duration. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12 and 5 to 16) values minus the baseline value.	Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16	mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1 to 4 measure the magnitude of pain (Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicate less interference of pain. Pain severity score was derived from the sum of responses of questions 1-4 and ranged from 0 (no pain) to 40 (worst possible pain) with lower scores indicates less pain. Results are reported for worst pain score, average pain score and pain severity score.	Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16
Number of Participants With Mean Average Daily Pain Score of Less Than or Equal to (<=) 2 at Weeks 1, 2, 4, 6, 8, 12 and 16	Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with average daily pain score of <=2 were reported.	Week 1, 2, 4, 6, 8, 12, 16
Number of Participants With Percent Reduction From Baseline in Average Daily Pain Score at Week 6	Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with specified percentage (%) of reduction in average daily pain scores from baseline at Week 6 were reported. Participants were counted more than once in different categories.	Baseline, Week 6
Number of Participants With at Least 30 Percent (%) and 50% Sustained Reduction From Baseline in Daily Average Pain Score at Week 6	Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days before Week 6 visit. Number of participants with >=30% or >=50% of sustained reduction (defined as reduction that was maintained for a minimum duration of 4 consecutive days) in average daily pain scores from baseline at Week 6 were reported.	Baseline, Week 6
Number of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16	Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Post-baseline weekly scores were calculated as the mean of average daily pain NRS scores over the past 7 days for each specified time point. Number of participants with >=30% or >=50% of reduction in average daily pain scores from baseline at Week 1, 2, 4, 6, 8, 12 and 16 were reported.	Baseline, Week 1, 2, 4, 6, 8, 12, 16
Time to Achieve at Least 30% (Percent) and 50% Sustained Reduction From Baseline in Average Daily Pain Score	Time to achieve >=30% or >=50% sustained reduction from baseline (defined as reduction from baseline that was maintained for a total of 4 consecutive days) in average daily pain score was summarized using the Kaplan-Meier estimates. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain.	Baseline up to Week 16
Total Duration of at Least 30 Percent (%) and 50% Reduction From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score in Participants	Total duration of response was defined as total number of days with a reduction of >=30% or >=50% in average daily pain score from baseline to Week 16. Participants assessed their average daily pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Total duration with at least of >=30% or >=50% percent reduction in average daily pain NRS scores from Baseline to Week 16 were reported.	Baseline to Week 16
Change From Baseline in Modified Brief Pain Inventory- Short Form (mBPI-sf) Score for Pain Interference With CS Score, GA Subtest and NW Subtest at Weeks 1, 2, 4, 6, 8, 12 and 16	mBPI-sf:questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions 1-4 assess magnitude of pain(Q1 for worst, Q2 for least, Q3 for average and Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists 7 item subsets which assess level of interference of pain on daily functions: 1: general activity (GA),2: mood, 3: walking ability, 4: normal work (NW),5: relations with other,6: sleep, 7: enjoyment of life. Each item assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. These 7 items were averaged to obtain pain interference composite score (CS), ranging from 0 (no interference) to 10 (complete interference), where lower scores =less interference of pain. Change from baseline in mBPI-sf score for pain interference with CS score, GA subtest and NW subtest were reported.	Baseline, Week 1, 2, 4, 6, 8, 12 and 16
Number of Participants With Change From Baseline in Patient's Global Assessment of Pain Score at Weeks 1, 2, 4, 6, 8, 12 and 16	Patient's global assessment of pain from post-herpetic neuralgia assessed participant's overall impression of disease activity. Participants answered: "Considering all the ways your pain from post-herpetic neuralgia, how are you doing today?". Participants responded using a 5--point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor) with lower scores indicating better condition. Number of participants who reported a change from Baseline of -4, -3, -2, -1, 0, 1, 2, 3, 4 in Patient's Global Assessment of Pain scores at each specified time-point were presented.	Baseline, Week 1, 2, 4, 6, 8 ,12, 16
Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication	Participants provided their response for patient's global evaluation of study medication by answering a question. Participants answered: "In all ways, how would you rate your overall response to the study medication today?" Participants responded using a 4-¬point likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicating better overall response to the treatment. Number of participants with each response level (poor, fair, good and excellent) were reported.	Week 1, 2, 4, 6, 8, 12, 16
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Score for Pain Interference With Sleep at Weeks 1, 2, 4, 6, 8 ,12 and 16	mBPI-sf is a self-administered questionnaire (5 questions) to assess pain severity and impact of pain on daily functions. Questions (Q) 1-4 assess magnitude of pain severity (Q1 for worst, Q2 for least, Q3 for average, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicate less pain. Question 5 consists of 7 item subsets which assess the level of interference of pain on daily functions: 1: general activity, 2: mood, 3: walking ability, 4: normal work, 5: relations with other, 6: sleep, 7: enjoyment of life. Each item was assessed on an 11-point NRS ranging from 0 (no interference) to 10 (complete interference), where lower scores indicated less interference of pain. Change from Baseline in mBPI-sf score for pain interference with sleep were reported.	Baseline, Week 1, 2, 4, 6, 8, 12, 16
Number of Participants Who Discontinued the Study Due to Lack of Efficacy		Baseline up to Week 16
Time to Discontinuation Due to Lack of Efficacy	Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.	Baseline up to Week 16
Number of Participants Who Used Rescue Medications	In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of participants with any use of rescue medication during the specified study week were summarized.	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
Duration of Rescue Medication Use	In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participant used rescue medication, during the specified weeks were summarized.	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
Amount of Rescue Medication Taken	In case of inadequate pain relief for post-herpetic neuralgia, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen (in mg) used during the specified week were summarized.	Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16
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 (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.	Baseline up to 112 days after the last dose of study drug (up to Week 16)
Number of Participants With Abnormal Physical Examinations Findings at Screening	Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid. Abnormalities in physical examination was based on investigator's discretion.	Screening visit (1 day prior to Day 1 baseline visit)
Number of Participants With Change From Baseline in Physical Examinations Findings at Week 16	Physical examination included the examination of abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, musculoskeletal assessment, neck, nose, skin, throat and thyroid.	Baseline, Week 16
Number of Participants With Change From Baseline in Neurological Examination Findings at Week 16	Neurological examination included the assessment of cranial nerve function, coordination, reflexes, proprioception, mental status, motor function, gait and station and sensory function (sharp sensation, warm/cold sensation, light touch, deep pressure, and vibration sensation).	Baseline, Week 16
Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Week 16	Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Criteria for clinically significant vital signs included: heart rate value of less than (<) 40 beats per minute and greater than (>) 150 beats per minute, systolic blood pressure (SBP) of <80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or >40 degree centigrade, respiratory rate of <10 or >50 breaths/minute.	Baseline, Week 16
Number of Participants With Laboratory Abnormalities	Abnormality criteria: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma GT, LDH, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3*ULN), electrolytes (sodium <0.95* LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1).	Baseline up to Week 16
Number of Participants With Electrocardiogram (ECG) Abnormalities	Criteria for abnormality in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.	Baseline up to Week 16
Number of Participants With Positive Anti-Drug Antibody (ADA) Response	Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for PF-04383119 were considered as ADA positive.	Baseline up to Week 16
Change From Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) at Week 2, 6, 12, 16 and End of Study	HVLT-R was a word-list learning and memory test used to assess the changes in memory. The task was repeated, for a total of 3 learning trials. After a delay interval of 20 to 25 minutes, delayed recall trial was administered. 1)Learning efficiency: Assessed by examining the learning curve over 3 learning trials and by evaluating the sum of the scores for all 3 learning trials. Raw scores for each of the 3 learning trials were summed for the total recall (TR) score. The TR score ranges from 0 to 36, where higher scores indicated greater verbal learning and recall, 2) Ability to access newly learned information: Assessed by the number of words retained on the delayed recall (DR) trial and the percentage of words recalled from the word list. DR trial score ranges from 0 to 12, where higher scores indicated greater verbal learning and recall.	Baseline, Week 2, 6, 12, 16, end of study (i.e. anytime up to Week 16)
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for Tanezumab	AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) for Tanezumab	Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
Plasma Concentration of Tanezumab at Nominal Collection Time of 1 Hours and 2688 Hours Postdose	Plasma concentration of tanezumab at nominal collection time of 1 hour post-dose (C1) and plasma concentration at nominal collection time of 2688 hours post-dose (C2688) were reported.	1, 2688 hours postdose on Day 1
Total Clearance of Tanezumab From Plasma	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing given intravenous dose by AUC inf. AUC inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
Terminal Elimination Half-Life (t1/2) of Tanezumab	Terminal elimination half-life is the time measured for the plasma concentration of tanezumab to decrease by one half of its original concentration.	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1
Volume of Distribution at Steady State (Vss) for Tanezumab	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.	Predose (0 hour) and 1, 2, 192, 193, 672, 673, 1008, 1009, 2016, 2017 and 2688 hours post dose on Day 1

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2007
• Primary Completion (Actual): December 20, 2008
• Study Completion (Actual): January 7, 2009

Study Registration Dates

• First Submitted: December 3, 2007
• First Submitted That Met QC Criteria: December 5, 2007
• First Posted (Estimate): December 6, 2007

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: monoclonal antibody
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tanezumab
• Other Study ID Numbers: A4091005; PHN POC (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.