Clinical study of gatifloxacin in prostatitis

M. Tsugawa, K. Monden, H. Kumon, H. Ohmori, K. Kondo, T. Kaneshige, S. Irie, M. Nishimura, T. Hayashi, T. Akaeda, Y. Maki, M. Kishi, M. Nishi, S. Hayata, S. Uno, Y. Nishitani, K. Hata, N. Ono, Daisuke Yamada

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

To evaluate the clinical efficacy, clinical cure effect and safety of gatifloxacin (GFLX), 8-methoxyquinolone derivatives, in prostatitis and the penetration of GFLX into prostatic fluid in healthy volunteers, we performed a clinical study. Six healthy volunteers received 200 mg of GFLX as a single oral dose and the drug's penetration into prostatic fluid at 2 and 4 hours was evaluated. Thirty-two patients orally received 200 mg b.i.d. of GFLX for 14 days and were evaluated on Day 7, 14 and 28, and the clinical efficacy was assessed in accordance with the criteria of the Japanese UTI Committee. 1. The concentrations of GFLX in prostatic fluid ranged from 0.65 to 2.20 and from 1.02 to 1.56 μg/mL, and concentration ratios to serum were 0.98 and 1.03 at 2 and 4 hours, respectively. 2. In acute bacterial prostatitis, including chronic bacterial prostatitis acutely aggravated, the overall clinical efficacy rate (excellent and moderate responses) was 100% (7/7) on Day 7. Also clinical cure rates on Day 14 (time of final dosing) and 28 (2 weeks after dosing) were 100% (6/6). 3. In chronic bacterial prostatitis, the overall clinical efficacy rate was 100% (9/9) on Day 14. On Day 28 (2 weeks after dosing), 7 of 7 patients were clinically cured. 4. The incidence of clinical adverse reactions was 6.3% of 32 patients, and of laboratory adverse reactions was 9.7% of 31 patients. None of the findings in adverse reactions were serious. From the results of this study, we conclude that GFLX penetrates the prostatic fluid well, and is safe and effective in the treatment of prostatitis.

Original languageEnglish
Pages (from-to)843-851
Number of pages9
JournalJapanese Journal of Chemotherapy
Volume47
Issue number12
Publication statusPublished - 1999

Fingerprint

Prostatitis
Healthy Volunteers
gatifloxacin
Clinical Studies
Safety
Incidence
Serum
Pharmaceutical Preparations

Keywords

  • AM-1155
  • Gatifloxacin

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Tsugawa, M., Monden, K., Kumon, H., Ohmori, H., Kondo, K., Kaneshige, T., ... Yamada, D. (1999). Clinical study of gatifloxacin in prostatitis. Japanese Journal of Chemotherapy, 47(12), 843-851.

Clinical study of gatifloxacin in prostatitis. / Tsugawa, M.; Monden, K.; Kumon, H.; Ohmori, H.; Kondo, K.; Kaneshige, T.; Irie, S.; Nishimura, M.; Hayashi, T.; Akaeda, T.; Maki, Y.; Kishi, M.; Nishi, M.; Hayata, S.; Uno, S.; Nishitani, Y.; Hata, K.; Ono, N.; Yamada, Daisuke.

In: Japanese Journal of Chemotherapy, Vol. 47, No. 12, 1999, p. 843-851.

Research output: Contribution to journalArticle

Tsugawa, M, Monden, K, Kumon, H, Ohmori, H, Kondo, K, Kaneshige, T, Irie, S, Nishimura, M, Hayashi, T, Akaeda, T, Maki, Y, Kishi, M, Nishi, M, Hayata, S, Uno, S, Nishitani, Y, Hata, K, Ono, N & Yamada, D 1999, 'Clinical study of gatifloxacin in prostatitis', Japanese Journal of Chemotherapy, vol. 47, no. 12, pp. 843-851.
Tsugawa M, Monden K, Kumon H, Ohmori H, Kondo K, Kaneshige T et al. Clinical study of gatifloxacin in prostatitis. Japanese Journal of Chemotherapy. 1999;47(12):843-851.
Tsugawa, M. ; Monden, K. ; Kumon, H. ; Ohmori, H. ; Kondo, K. ; Kaneshige, T. ; Irie, S. ; Nishimura, M. ; Hayashi, T. ; Akaeda, T. ; Maki, Y. ; Kishi, M. ; Nishi, M. ; Hayata, S. ; Uno, S. ; Nishitani, Y. ; Hata, K. ; Ono, N. ; Yamada, Daisuke. / Clinical study of gatifloxacin in prostatitis. In: Japanese Journal of Chemotherapy. 1999 ; Vol. 47, No. 12. pp. 843-851.
@article{cb9a308c5bd74a5fa826c038b68ba463,
title = "Clinical study of gatifloxacin in prostatitis",
abstract = "To evaluate the clinical efficacy, clinical cure effect and safety of gatifloxacin (GFLX), 8-methoxyquinolone derivatives, in prostatitis and the penetration of GFLX into prostatic fluid in healthy volunteers, we performed a clinical study. Six healthy volunteers received 200 mg of GFLX as a single oral dose and the drug's penetration into prostatic fluid at 2 and 4 hours was evaluated. Thirty-two patients orally received 200 mg b.i.d. of GFLX for 14 days and were evaluated on Day 7, 14 and 28, and the clinical efficacy was assessed in accordance with the criteria of the Japanese UTI Committee. 1. The concentrations of GFLX in prostatic fluid ranged from 0.65 to 2.20 and from 1.02 to 1.56 μg/mL, and concentration ratios to serum were 0.98 and 1.03 at 2 and 4 hours, respectively. 2. In acute bacterial prostatitis, including chronic bacterial prostatitis acutely aggravated, the overall clinical efficacy rate (excellent and moderate responses) was 100{\%} (7/7) on Day 7. Also clinical cure rates on Day 14 (time of final dosing) and 28 (2 weeks after dosing) were 100{\%} (6/6). 3. In chronic bacterial prostatitis, the overall clinical efficacy rate was 100{\%} (9/9) on Day 14. On Day 28 (2 weeks after dosing), 7 of 7 patients were clinically cured. 4. The incidence of clinical adverse reactions was 6.3{\%} of 32 patients, and of laboratory adverse reactions was 9.7{\%} of 31 patients. None of the findings in adverse reactions were serious. From the results of this study, we conclude that GFLX penetrates the prostatic fluid well, and is safe and effective in the treatment of prostatitis.",
keywords = "AM-1155, Gatifloxacin",
author = "M. Tsugawa and K. Monden and H. Kumon and H. Ohmori and K. Kondo and T. Kaneshige and S. Irie and M. Nishimura and T. Hayashi and T. Akaeda and Y. Maki and M. Kishi and M. Nishi and S. Hayata and S. Uno and Y. Nishitani and K. Hata and N. Ono and Daisuke Yamada",
year = "1999",
language = "English",
volume = "47",
pages = "843--851",
journal = "Japanese Journal of Chemotherapy",
issn = "1340-7007",
publisher = "Japan Society of Chemotherapy",
number = "12",

}

TY - JOUR

T1 - Clinical study of gatifloxacin in prostatitis

AU - Tsugawa, M.

AU - Monden, K.

AU - Kumon, H.

AU - Ohmori, H.

AU - Kondo, K.

AU - Kaneshige, T.

AU - Irie, S.

AU - Nishimura, M.

AU - Hayashi, T.

AU - Akaeda, T.

AU - Maki, Y.

AU - Kishi, M.

AU - Nishi, M.

AU - Hayata, S.

AU - Uno, S.

AU - Nishitani, Y.

AU - Hata, K.

AU - Ono, N.

AU - Yamada, Daisuke

PY - 1999

Y1 - 1999

N2 - To evaluate the clinical efficacy, clinical cure effect and safety of gatifloxacin (GFLX), 8-methoxyquinolone derivatives, in prostatitis and the penetration of GFLX into prostatic fluid in healthy volunteers, we performed a clinical study. Six healthy volunteers received 200 mg of GFLX as a single oral dose and the drug's penetration into prostatic fluid at 2 and 4 hours was evaluated. Thirty-two patients orally received 200 mg b.i.d. of GFLX for 14 days and were evaluated on Day 7, 14 and 28, and the clinical efficacy was assessed in accordance with the criteria of the Japanese UTI Committee. 1. The concentrations of GFLX in prostatic fluid ranged from 0.65 to 2.20 and from 1.02 to 1.56 μg/mL, and concentration ratios to serum were 0.98 and 1.03 at 2 and 4 hours, respectively. 2. In acute bacterial prostatitis, including chronic bacterial prostatitis acutely aggravated, the overall clinical efficacy rate (excellent and moderate responses) was 100% (7/7) on Day 7. Also clinical cure rates on Day 14 (time of final dosing) and 28 (2 weeks after dosing) were 100% (6/6). 3. In chronic bacterial prostatitis, the overall clinical efficacy rate was 100% (9/9) on Day 14. On Day 28 (2 weeks after dosing), 7 of 7 patients were clinically cured. 4. The incidence of clinical adverse reactions was 6.3% of 32 patients, and of laboratory adverse reactions was 9.7% of 31 patients. None of the findings in adverse reactions were serious. From the results of this study, we conclude that GFLX penetrates the prostatic fluid well, and is safe and effective in the treatment of prostatitis.

AB - To evaluate the clinical efficacy, clinical cure effect and safety of gatifloxacin (GFLX), 8-methoxyquinolone derivatives, in prostatitis and the penetration of GFLX into prostatic fluid in healthy volunteers, we performed a clinical study. Six healthy volunteers received 200 mg of GFLX as a single oral dose and the drug's penetration into prostatic fluid at 2 and 4 hours was evaluated. Thirty-two patients orally received 200 mg b.i.d. of GFLX for 14 days and were evaluated on Day 7, 14 and 28, and the clinical efficacy was assessed in accordance with the criteria of the Japanese UTI Committee. 1. The concentrations of GFLX in prostatic fluid ranged from 0.65 to 2.20 and from 1.02 to 1.56 μg/mL, and concentration ratios to serum were 0.98 and 1.03 at 2 and 4 hours, respectively. 2. In acute bacterial prostatitis, including chronic bacterial prostatitis acutely aggravated, the overall clinical efficacy rate (excellent and moderate responses) was 100% (7/7) on Day 7. Also clinical cure rates on Day 14 (time of final dosing) and 28 (2 weeks after dosing) were 100% (6/6). 3. In chronic bacterial prostatitis, the overall clinical efficacy rate was 100% (9/9) on Day 14. On Day 28 (2 weeks after dosing), 7 of 7 patients were clinically cured. 4. The incidence of clinical adverse reactions was 6.3% of 32 patients, and of laboratory adverse reactions was 9.7% of 31 patients. None of the findings in adverse reactions were serious. From the results of this study, we conclude that GFLX penetrates the prostatic fluid well, and is safe and effective in the treatment of prostatitis.

KW - AM-1155

KW - Gatifloxacin

UR - http://www.scopus.com/inward/record.url?scp=0033392964&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033392964&partnerID=8YFLogxK

M3 - Article

VL - 47

SP - 843

EP - 851

JO - Japanese Journal of Chemotherapy

JF - Japanese Journal of Chemotherapy

SN - 1340-7007

IS - 12

ER -