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Clinical Cancer Research
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A Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Rofecoxib, a Selective Cyclooxygenase-2 Inhibitor, on Rectal Polyps in Familial Adenomatous Polyposis Patients

Tetsuro Higuchi, Takeo Iwama, Keigo Yoshinaga, Masahiro Toyooka, Makoto M. Taketo and Kenichi Sugihara
Tetsuro Higuchi
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Takeo Iwama
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Keigo Yoshinaga
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Masahiro Toyooka
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Makoto M. Taketo
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Kenichi Sugihara
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DOI:  Published October 2003
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    Fig. 1.

    Mean percentage of change from base line in the number of polyps; bars, ±SE. At 9 months, the polyp number in the group given rofecoxib decreased by 6.8% from the baseline values, whereas in the group of placebo, it increased by 3.1%. The 9.9% difference between the rofecoxib and placebo groups was statistically significant (P = 0.004).

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    Fig. 2.

    Mean percentage of change from base line in the size of polyps; bars, ±SE. At 9 months, the group given rofecoxib was associated with a significant reduction from the baseline in the size of rectal polyps as compared with the placebo group (−16.2% versus 1.5%; P < 0.001).

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    Schedule of the study

    MonthsBaselineTreatment periodPost-treatment period
    123456789101112Discontinuation
    ColonoscopyXXXXXX
    GastroduodenoscopyXXXX
    Physical examinationXXXXXXXXXXXXXX
    Blood pressure, body weightXXXXXXXXX
    Laboratory testsXXXXXXXXX
  • Table 2

    Baseline characteristics of the patients with familial adenomatous polyposisa

    CharacteristicPlacebo n = 9Rofecoxib n = 12
    Ageyr.33.6 ± 14.832.3 ± 11.2
    Genderno. (%)
     Male4 (44.4)7 (58.3)
     Female5 (55.6)5 (41.7)
    Heightcm161.2 ± 7.2162.7 ± 4.5
    Weightkg57.7 ± 12.951.8 ± 7.4
    Surgical statusno. (%)
     Intact colon3 (33.3)5 (41.7)
     Colectomy6 (66.7)7 (58.3)
    No. of polyps7.2 ± 3.38.0 ± 4.5
    Polyp sizemm3.3 ± 0.83.0 ± 0.7
    • a Plus-minus values are means ± SD.

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Clinical Cancer Research: 9 (13)
October 2003
Volume 9, Issue 13
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A Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Rofecoxib, a Selective Cyclooxygenase-2 Inhibitor, on Rectal Polyps in Familial Adenomatous Polyposis Patients
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A Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Rofecoxib, a Selective Cyclooxygenase-2 Inhibitor, on Rectal Polyps in Familial Adenomatous Polyposis Patients
Tetsuro Higuchi, Takeo Iwama, Keigo Yoshinaga, Masahiro Toyooka, Makoto M. Taketo and Kenichi Sugihara
Clin Cancer Res October 15 2003 (9) (13) 4756-4760;

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A Randomized, Double-Blind, Placebo-Controlled Trial of the Effects of Rofecoxib, a Selective Cyclooxygenase-2 Inhibitor, on Rectal Polyps in Familial Adenomatous Polyposis Patients
Tetsuro Higuchi, Takeo Iwama, Keigo Yoshinaga, Masahiro Toyooka, Makoto M. Taketo and Kenichi Sugihara
Clin Cancer Res October 15 2003 (9) (13) 4756-4760;
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