NCT01314482Unknown2 期
The Efficacy of Prophylactic Administration of Minocycline in Reducing Chronic Intercostal Neuralgia Post-thoracotomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Daily pain scores on a numerical rating scale
研究概览
简要总结
In about half the patients who have an open chest surgery there is persistent severe pain in the chest. The investigators are examining whether minocycline, a commonly used antibiotic, will prevent pain. Minocycline blocks the activity of immune cells which the investigators believe are responsible for prolonging the pain.
详细描述
The study is of double-blind placebo controlled parallel groups design in up to 116 patients undergoing elective open thoracotomy. Minocycline 200mg twice daily or matching placebo are given three days before surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Aged 18 years or older
- •Undertaking elective, open thoracotomy with ample time pre-operatively to provide informed consent and undertake dosing
- •Sufficient fluency in English language to read and understand consent form, fulfil study requirements and communicate with research staff
- •Negative pregnancy test at screening for women of child bearing potential
- •Females of child bearing potential must agree to use a medically acceptable method of contraception other than oral contraceptives from time of first dosing until one week post-operatively. Acceptable methods include abstinence, contraceptive patches, NuvaRing (etonogestrel/ethinyl oestradiol vaginal ring), diaphragm with vaginal spermicide, intrauterine device, condom and vaginal spermicide, progestin implant or injection
- •Avoid prolonged, direct sunlight or ultra-violet light exposure during dosing period
- •Refrain from strenuous activities and avoid changes to regular exercise patterns throughout trial period
排除标准
- •Pregnant or breast feeding
- •Known allergy to minocycline and other tetracycline antibiotics
- •Pre-existing neuralgic pain condition in area designated for operation
- •Physical abnormality in area designated for operation
- •Taking disallowed concomitant medication
- •Renal insufficiency as determined by a calculated creatinine clearance of < 60mL/min
- •Hepatic dysfunction as determined by alanine transaminase and/or aspartate transaminase in excess of three times upper normal limits
- •Diagnosis of systemic lupus erythematosus
- •Recent diagnosis of enterocolitis or colitis
- •Participation in another trial of an investigational product within 30 days of commencing dosing or are scheduled to commence trial of an investigational product during study period
- •Patients who, in an Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
- •History of major psychiatric disorder not medically controlled
研究组 & 干预措施
Minocycline
Experimental
干预措施: Minocycline (Drug)
结局指标
主要结局
Daily pain scores on a numerical rating scale
时间窗: 3 months
次要结局
- Hypo/hyperaesthesia to punctate sensation(3 months)
研究者
Prof Paul Rolan
Professor of Clinical Pharmacology
University of Adelaide
研究点 (1)
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