EUCTR2008-006762-29-GB进行中（未招募）不适用
A double-blind, randomised, crossover, single dose, single centre, study examining the analgesic efficacy and tolerability of fixed-dose combinations of ibuprofen 200mg and acetaminophen 500mg, ibuprofen 400mg and acetaminophen 1,000mg and placebo in primary dysmenorrhoea. - Dysmenorrhoea Efficacy Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- Female
入选标准
- •1)Age: =18
- •2)Sex: Female
- •3)Primary diagnosis: Primary Dysmenorrhoea, with moderat-severe cramping pain in at least 4 of the previous 6 months.
- •4)Status: These subjects will be members of the public who respond to any study specific advertising, or have indicated to staff that they wish to participate in a dysmenorrhoea trial.
- •5)Subjects who have given written informed consent
- •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
- •1)A history of significant disease deemed by the investigator to render the subject unsuitable for inclusion.
- •2)Any significant ongoing painful condition other than that associated with primary dysmenorrhoea.
- •3)Any ongoing condition that may interfere with the absorption, distribution, metabolism, or excretion of the study medication.
- •4)A history of peptic ulcer, duodenal ulcer, gastrointestinal bleeding.
- •5)A history of frequent dyspepsia, heartburn or indigestion.
- •6)A history of psychotic illness, attempted suicide, or neurosis.
- •7)A positive history of drug or alcohol abuse within the past year.
- •8)Those taking any concomitant medications that might confound assessments of pain relief, such as psychotropic drugs, antidepressants, sedative –hypnotics taken within fives times of their elimination half lives. Selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) are permitted if the subject has been on a stable dose for at least four weeks prior to Visit 1 (screening) and remain on this dose throughout the study.
- •9)Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the subject become sexually active, she must agree to use a double barrier method] or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
- •10)A history of inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any previous history of allergy or known intolerance to any of the drugs or formulation constituents which, in the Investigator’s opinion, might preclude use of an NSAID, including aspirin sensitive asthma or a previous allergic response to a NSAID, including bronchospasm, urticaria, angioedema and rhinitis.
- •11)Those previously randomised into this study
- •12)Subjects who have received any analgesic, anti-inflammatory, antispasmodic or other therapy for dysmenorrhoea within 6 hours of taking the study medication.
- •13)Those who have participated in a clinical trial in the previous 30 days weeks are calculated from time of last dosing in the prior trial to time of anticipated dosing in this trial.
- •14)Those suffering with anaemia – (blood test at screening visit)
- •Those unable, in the opinion of the investigator, to comply fully with the study requirements
研究者
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Dysmenorrhoea Efficacy Study: fixed dose combination tablets of ibuprofen and acetaminophen for primary dysmenorrhoeaPrimary dysmenorrhoeaUrological and Genital DiseasesPain and other conditions associated with female genital organs and menstrual cycleISRCTN42521357Reckitt Benckiser Healthcare (UK)85
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