NCT01562717已完成3 期
A Randomised, Multicentre, Two-arm, Parallel Group, Double-blind, Placebo-controlled, Comparative Efficacy and Safety Clinical Study of Ibuprofen in Patients With Pain Related to Uncomplicated Ankle Injuries
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Efficacy: VAS
研究概览
简要总结
The objective of the study is to evaluate the efficacy and safety of Ibuprofen in patients with ankle injuries.
详细描述
The objective of the study is to evaluate the efficacy and safety of Ibuprofen versus placebo in patients for the treatment of pain related to uncomplicated ankle injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained.
- •Male and female patients, age in the range of 18-45 years (inclusive).
- •Patients with pain related to uncomplicated ankle injuries (in case of doubt whether it is complicated an X-ray should be taken).
- •Pain related to ankle injuries is scored as moderate or severe by the patient and the injury is less than 24 hours old.
- •Patients with normal or clinically non-significant findings as determined by baseline history, physical examination and vital signs (blood pressure, heart rate and axillary temperature).
- •Comprehension of the nature and purpose of the study and compliance with the protocol requirements.
- •Negative urine pregnancy test (for females only).
排除标准
- •Known hypersensitivity to aspirin or any non-steroidal anti-inflammatory drugs (NSAID).
- •Known history of asthma.
- •Known history of gastric or peptic ulcer or bleeding.
- •Known history of malignancy or other serious diseases.
- •Known history of skin allergy.
- •Known history of cardiac, renal or hepatic insufficiency.
- •Presence of bruises or rash on the skin of ankle.
- •Presence of skin lesions like eczema or psoriasis.
- •Arthritis in the same joint.
- •Alcohol use during the study period or within 48 hours before the study enrolment.
- •Patients judged unable to use the VAS for pain reliably
- •Locally applied NSAID to the painful region/area of study or oral use of NSAID or other analgesics 48 hours before the study enrolment.
- •Other pain killers than rescue medication to be taken during the study.
- •Recurrent sprain at the same joint during the last 6 months.
- •Anticoagulant therapy.
- •Physiotherapy during study period.
- •Open wounds, infected skin or fracture.
- •Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the patient.
- •Pregnant or lactating females.
- •Participation in a drug or device study within 90 days before the study enrolment.
研究组 & 干预措施
Ibuprofen
Experimental
干预措施: Ibuprofen (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy: VAS
时间窗: Day 7
VAS pain score change over time from baseline to day 7
次要结局
- Efficacy: VAS(Day 3 and Day 7)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Ibuprofen in Patients With Ankle InjuriesPainNCT01563289Orion Corporation, Orion Pharma62
终止
3 期
A Multicenter Trial of the Efficacy and Safety of a New Formulation of Ibuprofen 800 mg Every 6 Hours in the Management of Postoperative PainPostoperative PainNCT02254525Biomendi S.A.U.231
已完成
3 期
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain StudyPost-operative PainNCT01229449Reckitt Benckiser LLC678
Unknown
3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.IbuprofenNonsteroidal Anti-inflammatory DrugIntravenousInjectablePainAnalgesicNCT04429282Yi Feng, MD396
已完成
3 期
Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile PatientsFeverNCT01131000Cumberland Pharmaceuticals123