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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02336685
Registration number
NCT02336685
Ethics application status
Date submitted
8/01/2015
Date registered
13/01/2015
Date last updated
2/10/2017
Titles & IDs
Public title
Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001
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Scientific title
Randomized, 16-Week, Multi-Phase, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fulranumab as Adjunctive Therapy in Subjects With Signs and Symptoms of Osteoarthritis of the Hip or Knee
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Secondary ID [1]
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42160443PAI3001
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Secondary ID [2]
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CR100068
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
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Pain
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Fulranumab 1 mg
Treatment: Drugs - Fulranumab 3 mg
Treatment: Drugs - Opioid
Placebo comparator: Placebo - Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of placebo during the double-blind treatment phase in addition to opioids as standard of care.
Experimental: Fulranumab 1 mg - Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 1 mg during the double-blind treatment phase in addition to opioids as standard of care.
Experimental: Fulranumab 3 mg - Participants will receive 4 subcutaneous (SC) injections (one injection every 4 weeks) of fulranumab 3 mg during the double-blind treatment phase in addition to opioids as standard of care.
Treatment: Drugs: Placebo
Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.
Treatment: Drugs: Fulranumab 1 mg
Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
Treatment: Drugs: Fulranumab 3 mg
Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
Treatment: Drugs: Opioid
Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score
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Assessment method [1]
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The WOMAC 3.1 is a multi-dimensional, osteoarthritis (OA) specific self-administered questionnaire using 24 questions with a 48-hour recall that are grouped into 3 subscales (pain, stiffness, and physical function) associated with hip or knee OA. Pain, stiffness, and physical function is rated on a scale of 0-10 (0 = less severe up to 10 = more severe).
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Timepoint [1]
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Baseline, Week 16
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Primary outcome [2]
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Change from baseline to the end of Week 16 in Western Ontario and McMaster University Arthritis Index (WOMAC) physical function subscale score
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Assessment method [2]
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See WOMAC 3.1 described above.
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Timepoint [2]
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Baseline, Week 16
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Primary outcome [3]
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Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score
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Assessment method [3]
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The PGA is part of a comprehensive assessment of the impact of treatment for osteoarthritis that also includes pain and physical function. The PGA included in the present study indicates the perception of osteoarthritis in the study joint at the current time. Ratings are provided on an 11-point numerical rating scale from 0 ("Very Good") to 10 ("Very Bad").
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Timepoint [3]
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Baseline, Week 16
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Secondary outcome [1]
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Change from baseline to the end of Week 16 in Patient Global Assessment (PGA) score
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Assessment method [1]
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See PGA described above.
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Timepoint [1]
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Baseline, Week 16
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Secondary outcome [2]
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Change from baseline to the end of Week 16 in WOMAC Stiffness subscale score
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Assessment method [2]
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See WOMAC 3.1 described above.
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Timepoint [2]
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Baseline, Week 16
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Secondary outcome [3]
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Change from baseline to the end of Week 16 in daily numerical rating scale (NRS) score
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Assessment method [3]
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The numerical rating scale (NRS) uses an 11-point scale to assess OA pain ranging from 0 to 10 with high scores representing greater symptom severity (0=no pain and 10=pain as bad as you can imagine).
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Timepoint [3]
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Baseline, Week 16
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Secondary outcome [4]
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Change from baseline to the end of Week 16 in Medical Outcomes Study (MOS) Sleep subscale scores
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Assessment method [4]
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The MOS Sleep Scale (acute version) contains 12 items that address aspects of sleep. Six subscale scores may be calculated including: daytime somnolence, sleep disturbances, snoring, shortness of breath or headache upon awaking, adequacy of sleep and amount of sleep plus a summary index of sleep disturbances. A higher score indicates worse sleep in most domains, but the amount of sleep and adequacy of sleep are scored in the opposite direction. The primary subscale of interest in this study is daytime somnolence.
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Timepoint [4]
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Baseline, Week 16
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Secondary outcome [5]
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Change from baseline to the end of Week 16 in Short-Form-36 (SF-36) subscale scores
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Assessment method [5]
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The SF-36 is a self-administered, generic, 36-item questionnaire designed to cover 8 domains of functional health status and well-being, physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scoring yields 8 subscales based on the 8 domains covered in the questionnaire. These scales are scored from 0 to 100 with higher scores indicating better health.
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Timepoint [5]
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Baseline, Week 16
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Secondary outcome [6]
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Change from baseline to the end of Week 16 in EuroQol, 5 dimensions, 5 levels (EQ-5D-5L) scale score
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Assessment method [6]
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The EQ-5D is a self-administered, standardized measure of health status designed to provide a generic measure of health for clinical and economic appraisal that includes the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D 5 level (5L) version will be used in this study. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable or extreme problems. A unique health state is defined by combining 1 level from each of the 5 dimensions.
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Timepoint [6]
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Baseline, Week 16
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Secondary outcome [7]
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Change from baseline to the end of Week 16 in the percentage of participants who are responders based on WOMAC pain and physical function subscale scores and PGA scale scores
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Assessment method [7]
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Responders are defined as participants with percent improvement equal to and above the threshold values for WOMAC pain and physical function subscale scores and PGA scale scores, reported separately.
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Timepoint [7]
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Baseline, Week 16
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Secondary outcome [8]
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Change from baseline to the end of Week 16 in the percentage of participants who are responders based on OMERACT-OARSI, MCII, and PASS scale scores
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Assessment method [8]
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Responders are defined as participants with percent improvement equal to and above the threshold values for Outcome Measures in Rheumatology initiative/Osteoarthritis Research Society International (OMERACT-OARSI), Minimal Clinically Important Improvement (MCII), and the Patient Acceptable Symptom State (PASS) scale scores.
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Timepoint [8]
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Baseline, Week 16
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Secondary outcome [9]
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Change from baseline to the end of Week 16 in the percentage of participants who use rescue medication and other osteoarthritis (OA) analgesia
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Assessment method [9]
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Use of rescue medication (acetaminophen/paracetamol) and other OA pain medication will be recorded weekly during the study.
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Timepoint [9]
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Baseline, Week 16
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Eligibility
Key inclusion criteria
* Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class =2) of the study joint
* Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint
* An unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids) and receiving an opioid at study entry; For participants in the USA and Canada: An unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids other than codeine or codeine combination products) and receiving an opioid (other than codeine or codeine combination products) at study entry
* Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA
* During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
* Unstable or progressive neurologic disorders
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/09/2016
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Sample size
Target
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Accrual to date
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Final
79
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Connecticut
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Delaware
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Florida
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Georgia
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Illinois
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Kansas
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Louisiana
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Maryland
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Massachusetts
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New Mexico
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New York
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Oklahoma
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Canada
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Ontario
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Hungary
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Baja
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Hungary
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Szeged
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Canterbury
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Newtown
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Tauranga
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Poland
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Bialystok
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Gdansk
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Myslenice
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Blackpool
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Cannock
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Mancheter
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Matrix Park Buckshow Willage
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Stourton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis that is not adequately controlled by current pain therapy.
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Trial website
https://clinicaltrials.gov/study/NCT02336685
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Trial related presentations / publications
Kelly KM, Sanga P, Zaki N, Wang S, Haeussler J, Louie J, Thipphawong J. Safety and efficacy of fulranumab in osteoarthritis of the hip and knee: results from four early terminated phase III randomized studies. Curr Med Res Opin. 2019 Dec;35(12):2117-2127. doi: 10.1080/03007995.2019.1653068. Epub 2019 Sep 13.
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02336685
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