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
介入
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