EUCTR2008-000846-30-IT进行中（未招募）不适用
Open-label, randomised, controlled, parallel group study for the evaluation of safety and efficacy of Diclofenac HPBCD 75 mg ampoules s.c. in comparison with Diclofenac HPBCD 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 - DIRECT
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- IBSA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult males and females in-patients aged ≥ 18 to ≤ 65 years; Subjects able and willing to give their written informed consent; Subjects undergoing one of the following minor orthopaedic interventions: arthroscopic meniscectomy, arthroscopic removal of bone fragments, surgical correction of hallux valgus; Presence of moderate to severe post-operative pain, defined as a level of at least 50 mm measured on a 0-100 mm visual analogue scale; Pain attack started not more than 6 hours from surgery; Physical examination results, including vital signs, within the reference ranges or without clinically significant abnormalities as judged by the Investigator; Preoperative laboratory tests (haematology, blood chemistry, urinalysis) performed within 2 weeks before V1, and instrumental tests (e.g. X rays, ECG), in the reference ranges or without clinically significant abnormalities as judged by the Investigator; Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) and must be willing to continue using it throughout the entire study period; Female subjects of childbearing potential must have a negative urine pregnancy test at the baseline visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence of systemic infection or infection at the site of operation; Complications occurring after the surgical procedure; Patients with clinical signs of or known gastro-duodenal ulcer; Patients with clinical signs or history of coagulation disorders, or with a history of recurrence ulceration or gastrointestinal bleeding; Alcohol or drug abuse < 1 year; Presence or intention of pregnancy and breast feeding; Patients with known hypersensitivity to Diclofenac or to other NSAID drugs, or to one of the components of the preparation; Patients under chronic treatment with topical or systemic analgesics/NSAIDs; Prior intake of systemic NSAIDs or analgesics in the 12 hours before surgery, opioids in the 7 days before surgery, or corticosteroids (by any administration route) in the 60 days before surgery; Concomitant use of drugs which may be susceptible to interactions with diclofenac or which may affect safety if used concomitantly (lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, steroids and diuretics); Clinically significant or unstable concurrent diseases whose sequeleae or treatment might interfere with the study evaluation parameters; Patients with hepatic impairment; renal impairment or heart failure (of any degree); Patients with metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the investigator, could compromise the patient?s participation in the study; Patients who have used any investigational drug/device and/or participated in any clinical trial in the previous 3 months; Patients who have been previously enrolled in this study; Patients unable to give a valid informed consent; Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
研究者
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