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日本語版IP-TNトライアル

基本情報

NCT ID
NCT02831569
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
80
治験依頼者名
Boehringer Ingelheim

概要

This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated with muscle strain. More than 90 patients will be screened to enroll approximately 80 patients in the trial. After giving written informed consent, patients will be enrolled in the trial. Patients who are considered eligible for the trial by the Investigator after consent and complete the trial procedures and assessments at Visit 1 will receive the trial medication and enter the open-label treatment period of 2 weeks. Patients who complete the open-label treatment period will enter the follow-up period of 1 week and complete the trial after confirmation at the last visit (or phone interview).

対象疾患

Pain

介入

Loxoprofen sodium(DRUG)
Methocarbamol(DRUG)

依頼者(Sponsor)

実施施設 (3)

独立行政法人地域医療機能推進機構 東京新宿メディカルセンター

Tokyo, Shinjyuku-ku, Japan

医療法人社団福和会 福和クリニック

Tokyo, Chuo-ku, Japan

医療法人社団旭和会 東京駅センタービルクリニック

Tokyo, Chuo-ku, Japan