Randomized Placebo-Controlled and Controlled Non-Inferiority Phase III Trials Comparing Trafermin, a Recombinant Human Fibroblast Growth Factor 2, and Enamel Matrix Derivative in Periodontal Regeneration in Intrabony Defects

Masahiro Kitamura, Motoki Akamatsu, Masamitsu Kawanami, Yasushi Furuichi, Takeo Fujii, Mari Mori, Kazushi Kunimatsu, Hidetoshi Shimauchi, Yorimasa Ogata, Matsuo Yamamoto, Taneaki Nakagawa, Shuichi Sato, Koichi Ito, Takefumi Ogasawara, Yuichi Izumi, Kazuhiro Gomi, Kazuhisa Yamazaki, Hiromasa Yoshie, Mitsuo Fukuda, Toshihide NoguchiShogo Takashiba, Hidemi Kurihara, Toshihiko Nagata, Takafumi Hamachi, Katsumasa Maeda, Makoto Yokota, Ryuji Sakagami, Yoshitaka Hara, Kazuyuki Noguchi, Toshi Furuuchi, Takashi Sasano, Enyu Imai, Masatoshi Ohmae, Hayuru Koizumi, Mitsuru Watanuki, Shinya Murakami

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

We investigated the efficacy, safety, and clinical significance of trafermin, a recombinant human fibroblast growth factor (rhFGF)-2, for periodontal regeneration in intrabony defects in Phase III trials. Study A, a multicenter, randomized, double-blind, placebo-controlled study, was conducted at 24 centers. Patients with periodontitis with 4-mm and 3-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 328 patients were randomly assigned (2:1) to receive 0.3% rhFGF-2 or placebo, and 323 patients received the assigned investigational drug during flap surgery. One of the co-primary endpoints, the percentage of bone fill at 36 weeks after drug administration, was significantly greater in the rhFGF-2 group at 37.131% (95% confidence interval [CI], 32.7502 to 41.5123; n=208) than it was in the placebo group at 21.579% (95% CI, 16.3571 to 26.8011; n=100; p

Original languageEnglish
JournalJournal of Bone and Mineral Research
DOIs
Publication statusAccepted/In press - 2015

Fingerprint

Fibroblast Growth Factor 2
Dental Enamel
Regeneration
Placebos
Confidence Intervals
Investigational Drugs
Periodontitis
Safety
Bone and Bones
Pharmaceutical Preparations
trafermin

Keywords

  • Cell/tissue signaling
  • Clinical trials
  • Cytokines
  • Dental biology
  • Endocrine pathways

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Randomized Placebo-Controlled and Controlled Non-Inferiority Phase III Trials Comparing Trafermin, a Recombinant Human Fibroblast Growth Factor 2, and Enamel Matrix Derivative in Periodontal Regeneration in Intrabony Defects. / Kitamura, Masahiro; Akamatsu, Motoki; Kawanami, Masamitsu; Furuichi, Yasushi; Fujii, Takeo; Mori, Mari; Kunimatsu, Kazushi; Shimauchi, Hidetoshi; Ogata, Yorimasa; Yamamoto, Matsuo; Nakagawa, Taneaki; Sato, Shuichi; Ito, Koichi; Ogasawara, Takefumi; Izumi, Yuichi; Gomi, Kazuhiro; Yamazaki, Kazuhisa; Yoshie, Hiromasa; Fukuda, Mitsuo; Noguchi, Toshihide; Takashiba, Shogo; Kurihara, Hidemi; Nagata, Toshihiko; Hamachi, Takafumi; Maeda, Katsumasa; Yokota, Makoto; Sakagami, Ryuji; Hara, Yoshitaka; Noguchi, Kazuyuki; Furuuchi, Toshi; Sasano, Takashi; Imai, Enyu; Ohmae, Masatoshi; Koizumi, Hayuru; Watanuki, Mitsuru; Murakami, Shinya.

In: Journal of Bone and Mineral Research, 2015.

Research output: Contribution to journalArticle

Kitamura, M, Akamatsu, M, Kawanami, M, Furuichi, Y, Fujii, T, Mori, M, Kunimatsu, K, Shimauchi, H, Ogata, Y, Yamamoto, M, Nakagawa, T, Sato, S, Ito, K, Ogasawara, T, Izumi, Y, Gomi, K, Yamazaki, K, Yoshie, H, Fukuda, M, Noguchi, T, Takashiba, S, Kurihara, H, Nagata, T, Hamachi, T, Maeda, K, Yokota, M, Sakagami, R, Hara, Y, Noguchi, K, Furuuchi, T, Sasano, T, Imai, E, Ohmae, M, Koizumi, H, Watanuki, M & Murakami, S 2015, 'Randomized Placebo-Controlled and Controlled Non-Inferiority Phase III Trials Comparing Trafermin, a Recombinant Human Fibroblast Growth Factor 2, and Enamel Matrix Derivative in Periodontal Regeneration in Intrabony Defects', Journal of Bone and Mineral Research. https://doi.org/10.1002/jbmr.2738
Kitamura, Masahiro ; Akamatsu, Motoki ; Kawanami, Masamitsu ; Furuichi, Yasushi ; Fujii, Takeo ; Mori, Mari ; Kunimatsu, Kazushi ; Shimauchi, Hidetoshi ; Ogata, Yorimasa ; Yamamoto, Matsuo ; Nakagawa, Taneaki ; Sato, Shuichi ; Ito, Koichi ; Ogasawara, Takefumi ; Izumi, Yuichi ; Gomi, Kazuhiro ; Yamazaki, Kazuhisa ; Yoshie, Hiromasa ; Fukuda, Mitsuo ; Noguchi, Toshihide ; Takashiba, Shogo ; Kurihara, Hidemi ; Nagata, Toshihiko ; Hamachi, Takafumi ; Maeda, Katsumasa ; Yokota, Makoto ; Sakagami, Ryuji ; Hara, Yoshitaka ; Noguchi, Kazuyuki ; Furuuchi, Toshi ; Sasano, Takashi ; Imai, Enyu ; Ohmae, Masatoshi ; Koizumi, Hayuru ; Watanuki, Mitsuru ; Murakami, Shinya. / Randomized Placebo-Controlled and Controlled Non-Inferiority Phase III Trials Comparing Trafermin, a Recombinant Human Fibroblast Growth Factor 2, and Enamel Matrix Derivative in Periodontal Regeneration in Intrabony Defects. In: Journal of Bone and Mineral Research. 2015.
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T1 - Randomized Placebo-Controlled and Controlled Non-Inferiority Phase III Trials Comparing Trafermin, a Recombinant Human Fibroblast Growth Factor 2, and Enamel Matrix Derivative in Periodontal Regeneration in Intrabony Defects

AU - Kitamura, Masahiro

AU - Akamatsu, Motoki

AU - Kawanami, Masamitsu

AU - Furuichi, Yasushi

AU - Fujii, Takeo

AU - Mori, Mari

AU - Kunimatsu, Kazushi

AU - Shimauchi, Hidetoshi

AU - Ogata, Yorimasa

AU - Yamamoto, Matsuo

AU - Nakagawa, Taneaki

AU - Sato, Shuichi

AU - Ito, Koichi

AU - Ogasawara, Takefumi

AU - Izumi, Yuichi

AU - Gomi, Kazuhiro

AU - Yamazaki, Kazuhisa

AU - Yoshie, Hiromasa

AU - Fukuda, Mitsuo

AU - Noguchi, Toshihide

AU - Takashiba, Shogo

AU - Kurihara, Hidemi

AU - Nagata, Toshihiko

AU - Hamachi, Takafumi

AU - Maeda, Katsumasa

AU - Yokota, Makoto

AU - Sakagami, Ryuji

AU - Hara, Yoshitaka

AU - Noguchi, Kazuyuki

AU - Furuuchi, Toshi

AU - Sasano, Takashi

AU - Imai, Enyu

AU - Ohmae, Masatoshi

AU - Koizumi, Hayuru

AU - Watanuki, Mitsuru

AU - Murakami, Shinya

PY - 2015

Y1 - 2015

N2 - We investigated the efficacy, safety, and clinical significance of trafermin, a recombinant human fibroblast growth factor (rhFGF)-2, for periodontal regeneration in intrabony defects in Phase III trials. Study A, a multicenter, randomized, double-blind, placebo-controlled study, was conducted at 24 centers. Patients with periodontitis with 4-mm and 3-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 328 patients were randomly assigned (2:1) to receive 0.3% rhFGF-2 or placebo, and 323 patients received the assigned investigational drug during flap surgery. One of the co-primary endpoints, the percentage of bone fill at 36 weeks after drug administration, was significantly greater in the rhFGF-2 group at 37.131% (95% confidence interval [CI], 32.7502 to 41.5123; n=208) than it was in the placebo group at 21.579% (95% CI, 16.3571 to 26.8011; n=100; p

AB - We investigated the efficacy, safety, and clinical significance of trafermin, a recombinant human fibroblast growth factor (rhFGF)-2, for periodontal regeneration in intrabony defects in Phase III trials. Study A, a multicenter, randomized, double-blind, placebo-controlled study, was conducted at 24 centers. Patients with periodontitis with 4-mm and 3-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 328 patients were randomly assigned (2:1) to receive 0.3% rhFGF-2 or placebo, and 323 patients received the assigned investigational drug during flap surgery. One of the co-primary endpoints, the percentage of bone fill at 36 weeks after drug administration, was significantly greater in the rhFGF-2 group at 37.131% (95% confidence interval [CI], 32.7502 to 41.5123; n=208) than it was in the placebo group at 21.579% (95% CI, 16.3571 to 26.8011; n=100; p

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KW - Clinical trials

KW - Cytokines

KW - Dental biology

KW - Endocrine pathways

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