Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

277

Participants

Timeline

Start Date

May 26, 2016

Primary Completion Date

June 11, 2019

Study Completion Date

June 11, 2019

Conditions
Low Back Pain
Interventions
DRUG

Celecoxib

Orally administered Celecoxib 100 mg twice daily for 56 weeks

BIOLOGICAL

Tanezumab 5 mg

Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks

BIOLOGICAL

Tanezumab 10 mg

Subcutaneous injection of tanezumab 10 mg every 8 weeks for 56 weeks

DRUG

Placebo for celecoxib

Orally administered the placebo twice daily for 56 weeks

BIOLOGICAL

Placebo for tanezumab

Subcutaneous injection of the placebo every 8 weeks for 56 weeks

Trial Locations (55)

465-0025

Meitoh Hospital, Nagoya

488-8585

Asahi Rosai Hospital, Owariasahi

289-2511

Asahi General Hospital, Asahi

272-0021

Sato Orthopedic Clinic, Ichikawa

813-0017

Fukuoka Mirai Hospital, Higashi-ku,Fukuoka

803-8505

Shinkokura Hospital, Kitakyushu

800-0296

Kyushu Rosai Hospital, Kokuraminami-ku,Kitakyushu

830-0011

Kurume University Hospital, Kurume

800-0057

Shin Komonji Hospital, Moji-ku, Kitakyusyu

969-1793

Fujita general Hospital, Date-gun

961-0092

Shirakawa Hospital, Shirakawa

078-8237

Toyooka Chuo Hospital, Asahikawa

040-8585

Hakodate Central General Hospital, Hakodate

041-0802

Hakodate Ohmura Orthopedic Hospital, Hakodate

674-0051

Okubo Hospital, Akashi

670-0976

Omuro Orthopedic Clinic, Himeji

675-1115

Medical corporate corporation hoshikai Onishi medical clinic, Kako-gun

651-0073

Kobe Red Cross Hospital, Kobe

663-8014

Nishinomiya Municipal Central Hospital, Nishinomiya

920-8650

National Hospital Organization Kanazawa Medical Center, Kanazawa

923-8507

Morita Hospital, Komatsu

252-0001

Sagamidai Hospital, Zama

614-8366

Misugikai Medical Corporation Otokoyama Hospital, Yawata

399-8701

National Hospital Organization Matsumoto Medical Center, Matsumoto

386-0603

Yodakubo Hospital, Nagawa-machi, Chisagata-gun

874-0011

National Hospital Organization Beppu Medical Center, Beppu

586-8521

National Hospital Organization Osaka Minami Medical Center, Kawachi-Nagano

596-8522

Kishiwada Tokushukai Hospital, Kishiwada

591-8025

Osaka Rosai Hospital, Sakai

590-0406

Nagayama Hospital, Sennan-gun

332-8558

Saiseikai Kawaguchi General Hospital, Kawaguchi

359-0047

Hanazono Orthopedics and Internal Medicine, Tokorozawa

434-8533

Japanese Red Cross Hamamatsu Hospital, Hamamatsu

438-8550

Iwata City Hospital, Iwata

108-0073

Tokyo Saiseikai Central Hospital, Minato-ku

108-8642

Kitasato University Kitasato Institute Hospital, Minato-ku

208-0011

National Hospital Organization Murayama Medical Center, Musashimurayama

177-0051

Gate Town Hospital, Nerima-ku

177-8521

Juntendo University Nerima Hospital, Nerima-ku

146-0094

Nishikamata Orthopedic, Ōta-ku

158-0082

AR-Ex Oyamadai Orthopedic, Setagaya-ku

140-0001

Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital, Shinagawa-ku

140-0014

Ohimachi Orthopaedic Clinic, Shinagawa-ku

167-0035

Ogikubo Hospital, Suginami-ku

167-0051

Medical Corporation Keiyukai Masumoto Orthopedic Clinic, Suginami-ku

171-0033

Daido Hospital, Toshima-ku

939-1395

Tonami General Hospital, Tonami

649-7113

Wakayama Medical University Kihoku Hospital, Ito-gun

750-8520

Shimonoseki City Hospital, Shimonoseki-shi

010-8543

Akita University Hospital, Akita

814-0165

Kuroda Orthopedic Hospital, Fukuoka

960-1295

Fukushima Medical University Hospital, Fukushima

530-0041

Morimoto Clinic, Osaka

547-0016

Nagayoshi General Hospital, Osaka

336-8522

Saitama Municipal Hospital, Saitama

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02725411 - Long Term Safety and Efficacy Study of Tanezumab in Japanese Adult Subjects With Chronic Low Back Pain | Biotech Hunter | Biotech Hunter