Clinical trial NCT02725411: Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain
Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN JAPANESE ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Chronic low back pain
Chronic pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-04-01
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the long-term safety and efficacy of a fixed dose of tanezumab 5 mg and 10 mg administered subcutaneously (SC) seven times at 8 week intervals. The primary objective of this study is to evaluate the long term safety of tanezumab 5 mg and 10 mg administrated SC every 8 weeks (7 administrations). In addition, the study will evaluate the long term analgesic efficacy of tanezumab 5 mg and 10 mg SC administered every 8 weeks (7 administrations).

Detailed description: This is a randomized, double-blind, active-controlled, multicenter, parallel-group Phase 3 study of the safety and efficacy of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio. Treatment groups will include: 1) Placebo SC matching tanezumab administered at an 8-week interval (total of 7 times) plus celecoxib 100 mg twice a day (BID) to be administered orally for 56 weeks; 2) Tanezumab 5 mg SC administered at an 8-week interval (total of 7 times) plus placebo matching celecoxib to be administered orally BID for 56 weeks; 3) Tanezumab 10 mg SC administered at an 8-week interval (total of 7 times) plus placebo matching celecoxib to be administered orally BID for 56 weeks. The study is designed with a total duration (post-randomization) of up to 80 weeks and will consist of three periods: Screening (up to 37 days; includes a Washout Period and an Initial Pain Assessment Period \[IPAP\]), a Double-blind Treatment Period (56 weeks) and a Follow-up Period (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 to 32 days), if required, and an IPAP (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must be experiencing some benefit (eg, analgesic effect) from their current stable dose regimen of oral NSAID (celecoxib, loxoprofen or meloxicam) treatment, be tolerating their NSAID regimen, be taking this medication regularly (defined as an average of at least 5 days per week) during the 30 day period prior to the Screening Visit.

Eligibility criteria: Inclusion Criteria:

* Duration of chronic low back pain for ≥3 months, and treatment with agents for low back pain for ≥3 months.
* Primary location of low back pain must be between the 12th thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders.
* Subjects must be experiencing some benefits from their current stable dose regimen of oral NSAID (celecoxib, loxoprofen or meloxicam) treatment as described in the protocol, be tolerating their NSAID regimen, be taking this medication regularly during the 30 day period prior to the Screening visit and must have had some improvement in low back pain, but still require additional pain relief at Screening.
* Subjects must maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period.
* Low Back Pain Intensity (LBPI) score of ≥5 at Screening.
* Subjects must be willing to discontinue all pain medications for chronic low back pain except rescue medication and investigational product and not use prohibited pain medications throughout the duration of the study.
* Female subjects of childbearing potential and at risk for pregnancy must agree to comply with protocol specified contraceptive requirements.

Exclusion Criteria:

* Subjects exceeding protocol defined BMI limits.
* Diagnosis of osteoarthritis of the knee or hip as defined by the ACR combined clinical and radiographic criteria.

  * Subjects who have Kellgren Lawrence Grade \> or =2 radiographic evidence of hip or Grade \> or =3 radiographic evidence of knee osteoarthritis will be excluded.
  * Subjects who have Kellgren Lawrence Grade \< or =2 radiographic evidence of knee osteoarthritis but who do not meet ACR criteria and do not have pain associated with their knee osteoarthritis will be allowed.
* Subjects with symptoms and radiologic findings consistent with osteoarthritis in the shoulder.
* History of lumbosacral radiculopathy within the past 2 years, history of spinal stenosis associated with neurological impairment, or history of neurogenic claudication.
* Back pain due to recent major trauma within 6 months prior to Screening.
* Surgical intervention during the past 6 months for the treatment of low back pain.
* Planned surgical procedure during the duration of the study.
* History or radiographic evidence of other diseases that could confound efficacy or safety assessments (eg, rheumatoid arthritis).
* History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
* History of osteonecrosis or osteoporotic fracture.
* History of significant trauma or surgery to a knee, hip, or shoulder within the previous year.
* Signs or symptoms of carpal tunnel syndrome in the one year prior to Screening.
* Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required.
* History of intolerance or hypersensitivity to celecoxib/acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of celecoxib/acetaminophen is contraindicated.
* Use of prohibited medications or prohibited non-pharmacological treatments without the appropriate washout period (if applicable) prior to Screening or IPAP.
* History of known alcohol, analgesic or narcotic abuse within 2 years of Screening.
* Presence of drugs of abuse or illegal drugs in the urine toxicology screen obtained at Screening.
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
* Signs and symptoms of clinically significant cardiac disease.
* Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening.
* Evidence of protocol defined orthostatic hypotension at Screening.
* Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening.
* Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities.
* History of cancer within 5 years prior to Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
* Expected to undergo a therapeutic procedure or to use any analgesic other than those specified in the protocol throughout the pre-treatment and treatment periods that is likely to confound assessment of analgesic efficacy or safety.
* Previous exposure to exogenous NGF or to an anti-NGF antibody.
* Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits.
* Positive Hepatitis B, Hepatitis C, or HIV tests at screening indicative of current infection.
* History, diagnosis, or signs and symptoms of clinically significant neurological disease or clinically significant psychiatric disorder.
* Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements.
* Participation in other investigational drug studies within protocol defined time limits.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to 24 weeks after last dose of study drug (up to Week 80)
measure: Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 24 weeks after last dose of study drug (up to Week 80)
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities
timeFrame: Baseline up to Week 80
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to Week 80
measure: Number of Participants With Confirmed Orthostatic Hypotension From Baseline up to Week 80
timeFrame: Baseline up to Week 80
measure: Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Week 24
timeFrame: Screening (up to 37 days before Day 1), Week 24
measure: Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Week 56
timeFrame: Screening, Week 56
measure: Change From Screening in Mean Total Symptom Impact Scores as Per Survey of Autonomic Symptoms (SAS) at Week 80
timeFrame: Screening, Week 80
measure: Change From Screening in Mean Total Symptom Impact Score as Per Survey of Autonomic Symptoms (SAS) at Early Termination Follow-up Visit 1
timeFrame: Screening, Early Termination Follow-up Visit 1 (at 8 weeks after last dose of tanezumab or placebo matched to tanezumab)
measure: Change From Screening in Mean Total Symptom Impact Scores as Per Survey of Autonomic Symptoms (SAS) at Early Termination Follow-up Visit 3
timeFrame: Screening, Early Termination Follow-up Visit 3 (at 24 weeks after last dose of tanezumab or placebo matched to tanezumab)
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Assessments
timeFrame: Baseline up to Week 16
measure: Percentage of Participants With Individual Adjudicated Joint Safety Outcome/Event
timeFrame: Baseline up to Week 80
measure: Observation Time-Adjusted Event Rate for an Individual Adjudicated Joint Safety Outcome/Event
timeFrame: Baseline (Day 1) up to Week 80
measure: Percentage of Participants With At Least 1 Total Joint Replacement
timeFrame: Baseline (Day 1) up to Week 80
measure: Observation Time-Adjusted Event Rate for Total Joint Replacement (TJR) Event
timeFrame: Baseline (Day 1) up to Week 80
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32
timeFrame: Baseline, Week 32
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40
timeFrame: Baseline, Week 40
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48
timeFrame: Baseline, Week 48
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 56
timeFrame: Baseline, Week 56
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 64
timeFrame: Baseline, Week 64
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 80
timeFrame: Baseline, Week 80
measure: Largest Change From Baseline in Neuropathy Impairment Score (NIS) to Any Post-baseline Visit
timeFrame: Baseline to any post-baseline visit (until Week 80)
measure: Number of Participants With Anti Tanezumab Antibodies From Baseline up to Week 80
timeFrame: Baseline up to Week 80
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: At Screening
Secondary outcomes:
measure: Change From Baseline in Average Low Back Pain Intensity (LBPI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Multiple Imputation
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Average Low Back Pain Intensity (LBPI) at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Scores at Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 56: Multiple Imputation
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Change From Baseline in the Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
measure: Percentage of Participants With Cumulative Percent Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56
timeFrame: Baseline, Weeks 16, 24 and 56
measure: Percentage of Participants With >=30 Percent (%), >=50%, >=70% and >=90% Reduction From Baseline in Weekly Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24, 40 and 56
timeFrame: Baseline, Weeks 16, 24, 40 and 56
measure: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Worst Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
measure: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Average Pain at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
measure: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference Index at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
measure: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
measure: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
measure: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 40, 56, and 64
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
measure: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Scores for Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 40, 56 and 64
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 40, 56 and 64
measure: Percentage of Participants With Chronic Low Back Pain Responders Index at Weeks 16, 24, 40 and 56
timeFrame: Weeks 16, 24, 40 and 56
measure: Percentage of Participants Achieving Change of >=2 Points From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 16, 24, 40 and 56
timeFrame: Baseline, Weeks 16, 24, 40 and 56
measure: European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Dimensions Scores at Baseline, Weeks 16 and 56
timeFrame: Baseline, Weeks 16 and 56
measure: European Quality of Life-5 Dimension-5 Levels (EQ-5D-5L): Overall Health Utility Score/ Index Value
timeFrame: Baseline, Weeks 16 and 56
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Work Time Missed Due to Chronic Low Back Pain at Weeks 16, 56 and 64
timeFrame: Baseline, Weeks 16, 56 and 64
measure: Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Impairment While Working Due to Chronic Low Back Pain at Weeks 16, 56 and 64
timeFrame: Baseline, Weeks 16, 56 and 64
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Overall Work Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64
timeFrame: Baseline, Weeks 16, 56 and 64
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Low Back Pain (WPAI:LBP)- Percent Activity Impairment Due to Chronic Low Back Pain at Weeks 16, 56 and 64
timeFrame: Baseline, Weeks 16, 56 and 64
measure: Number of Participants Who Discontinued Due to Lack of Efficacy
timeFrame: Baseline up to Week 56
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 56
measure: Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
measure: Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
measure: Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64: Observed Data
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
measure: Number of Days of Rescue Medication Use During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: LOCF
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
measure: Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: Observed Data
timeFrame: Weeks 2, 4, 8, 12 and 16
measure: Amount of Rescue Medication Used in Weeks 2, 4, 8, 12, and 16: LOCF
timeFrame: Weeks 2, 4, 8, 12 and 16
measure: Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Participants Visited to the Emergency Room Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Scores at Weeks 16 and 56
timeFrame: Weeks 16 and 56
measure: Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Willingness to Use Study Drug Again
timeFrame: Weeks 16 and 56
measure: Number of Participants Responding to Patient Reported Treatment Impact Assessment-Modified (mPRTI) at Weeks 16 and 56 for Preference of Study Drug Versus Prior Treatment
timeFrame: Weeks 16 and 56
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Meitoh Hospital
state: Aichi
city: Owariasahi
country: Japan
facility: Asahi Rosai Hospital
state: Aichi
city: Asahi
country: Japan
facility: Asahi General Hospital
state: Chiba
city: Ichikawa
country: Japan
facility: Sato Orthopedic Clinic
state: Chiba
city: Higashi-ku,Fukuoka
country: Japan
facility: Fukuoka Mirai Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Shinkokura Hospital
state: Fukuoka
city: Kokuraminami-ku,Kitakyushu
country: Japan
facility: Kyushu Rosai Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Moji-ku, Kitakyusyu
country: Japan
facility: Shin Komonji Hospital
state: Fukuoka
city: Date-gun
country: Japan
facility: Fujita general Hospital
state: Fukushima
city: Shirakawa
country: Japan
facility: Shirakawa Hospital
state: Fukushima
city: Asahikawa
country: Japan
facility: Toyooka Chuo Hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Central General Hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Ohmura Orthopedic Hospital
state: Hokkaido
city: Akashi
country: Japan
facility: Okubo Hospital
state: Hyogo
city: Himeji
country: Japan
facility: Omuro Orthopedic Clinic
state: Hyogo
city: Kako-gun
country: Japan
facility: Medical corporate corporation hoshikai Onishi medical clinic
state: Hyogo
city: Kobe
country: Japan
facility: Kobe Red Cross Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Nishinomiya Municipal Central Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
state: Ishikawa
city: Komatsu
country: Japan
facility: Morita Hospital
state: Ishikawa
city: Zama
country: Japan
facility: Sagamidai Hospital
state: Kanagawa
city: Yawata
country: Japan
facility: Misugikai Medical Corporation Otokoyama Hospital
state: Kyoto
city: Matsumoto
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
state: Nagano
city: Nagawa-machi, Chisagata-gun
country: Japan
facility: Yodakubo Hospital
state: Nagano
city: Beppu
country: Japan
facility: National Hospital Organization Beppu Medical Center
state: Oita
city: Kawachinagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
state: Osaka
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Sakai
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
city: Sennan-gun
country: Japan
facility: Nagayama Hospital
state: Osaka
city: Kawaguchi
country: Japan
facility: Saiseikai Kawaguchi General Hospital
state: Saitama
city: Tokorozawa
country: Japan
facility: Hanazono Orthopedics and Internal Medicine
state: Saitama
city: Hamamatsu
country: Japan
facility: Japanese Red Cross Hamamatsu Hospital
state: Shizuoka
city: Iwata
country: Japan
facility: Iwata City Hospital
state: Shizuoka
city: Minato-ku
country: Japan
facility: Tokyo Saiseikai Central Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
state: Tokyo
city: Musashimurayama
country: Japan
facility: National Hospital Organization Murayama Medical Center
state: Tokyo
city: Nerima-ku
country: Japan
facility: Gate Town Hospital
state: Tokyo
city: Nerima-ku
country: Japan
facility: Juntendo University Nerima Hospital
state: Tokyo
city: Ota-ku
country: Japan
facility: Nishikamata Orthopedic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: AR-Ex Oyamadai Orthopedic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Ohimachi Orthopaedic Clinic
state: Tokyo
city: Suginami-ku
country: Japan
facility: Ogikubo Hospital
state: Tokyo
city: Suginami-ku
country: Japan
facility: Medical Corporation Keiyukai Masumoto Orthopedic Clinic
state: Tokyo
city: Toshima-ku
country: Japan
facility: Daido Hospital
state: Tokyo
city: Tonami
country: Japan
facility: Tonami General Hospital
state: Toyama
city: Ito-gun
country: Japan
facility: Wakayama Medical University Kihoku Hospital
state: Wakayama
city: Shimonoseki-shi
country: Japan
facility: Shimonoseki City Hospital
state: Yamaguchi
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: Kuroda Orthopedic Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Osaka
country: Japan
facility: Morimoto Clinic
city: Osaka
country: Japan
facility: Nagayoshi General Hospital
city: Saitama
country: Japan
facility: Saitama Municipal Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Konno SI, Nikaido T, Markman JD, Ohta M, Machida T, Isogawa N, Yoshimatsu H, Viktrup L, Brown MT, West CR, Verburg KM. Tanezumab for chronic low back pain: a long-term, randomized, celecoxib-controlled Japanese Phase III safety study. Pain Manag. 2022 Apr;12(3):323-335. doi: 10.2217/pmt-2021-0040. Epub 2021 Nov 17.