Open-label, randomised, controlled, parallel group study for the evaluation of safety and efficacy of DIclofenac HPßCD 75 mg ampoules s.c. in compaRison with DiclofEnaC HPßCD 75 mg ampoules i.m. and Voltaren® 75 mg ampoules i.m. in the treatment of acute moderate to severe pain following minor orThopaedic surgery

Institut Biochimique SA (IBSA) (Italy)0 个研究点目标入组 325 人开始时间: 2013年3月22日最近更新: 2022年5月30日

试验速览

暂无简介。

•1. Adult males and females in-patients aged = 18 to = 65 years
•2. Subjects undergoing one of the following minor orthopaedic surgeries:
•2.1. Arthroscopic meniscectomy
•2.2. Arthroscopic removal of bone fragments
•2.3. Surgical correction of hallux valgus
•2.4. Presence of moderate to severe post-operative pain, scored as = 40 mm on a 0-100 mm Visual Analogue Scale (VAS)
•2.5. Pain starting not more than 6 hours since surgery

•1. Patients with evidence of systemic infection or infection at the site of operation
•2. Complications occurring after surgical procedure
•3. Patients with clinical signs or a diagnosis of known gastroduodenal ulcer
•4. Patients with clinical signs or history of coagulation disorders, or with a history of recurrence ulceration or gastrointestinal (GI) bleeding
•5. Patients under chronic treatment with topical or systemic analgesics / Nonsteroidal anti-inflammatory drugs (NSAIDs)
•6. Intake of any systemic NSAID or analgesic in the last 12 hours before surgery
•7. Opioids in the 7 days before surgery, or corticosteroids (by any administration route) in the 60 days before surgery

发起方

Institut Biochimique SA (IBSA) (Italy)