🏥 治験ポータル
← 治験一覧に戻る

大腸内視鏡検査を受けた患者におけるNPF-08の研究

基本情報

NCT ID
NCT03794310
ステータス
完了
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
632
治験依頼者名
Nihon Pharmaceutical Co., Ltd

概要

To study non-inferiority of intestinal cleansing effect in both NPF-08 1-day treatment group and NPF-08 2-day split dose group to the cleansing effect in Moviprep® 1-day treatment group, for the subjects who will receive endoscopy large bowel. If the non-inferiority will be validated, superiority of intestinal cleansing effect in both groups of NPF-08 will be studied. Furthermore, for the assessment of safety of NPF-08, the adverse events and adverse drug reactions observed after the administration to post-examination period will be studied, compared to those at Moviprep® 1-day treatment group.

対象疾患

Patients Who Receive Colonoscopy

介入

NPF-08 (1-day treatment)(DRUG)
NPF-08 (2-day split dose)(DRUG)
Moviprep(1-day treatment)(DRUG)

依頼者(Sponsor)

Nihon(INDUSTRY)

実施施設 (13)

NPF-08 Trial Site 11

Kashiwa, Chiba, Japan

NPF-08 Trial Site 13

Kouchi, Japan

NPF-08 Trial Site 8

Hiroshima, Japan

NPF-08 Trial Site 6

Osaka, Japan

NPF-08 Trial Site 1

Maebashi, Gunnma, Japan

NPF-08 Trial Site 4

Shinjuku-Ku, Tokyo, Japan

NPF-08 Trial Site 12

Abiko, Chiba, Japan

NPF-08 Trial Site 5

Yokohama, Kanagawa, Japan

NPF-08 Trial Site 10

Kawasaki, Kanagawa, Japan

NPF-08 Trial Site 7

Osaka, Japan

NPF-08 Trial Site 3

Minato-Ku, Tokyo, Japan

NPF-08 Trial Site 9

Yokohama, Kanagawa, Japan

NPF-08 Trial Site 2

Chuo-Ku, Tokyo, Japan