ISRCTN32847177已完成未知
A multi-centre, double-blind, placebo-controlled, multiple-dose crossover proof of concept study to compare the efficacy of mefenamic acid administered vaginally and orally in healthy menstruating women with primary dysmenorrhoea requiring analgesia
Plethora Solutions Limited (UK)0 个研究点目标入组 105 人开始时间: 2007年10月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Healthy menstruating female with a history of primary dysmenorrhoea
- •2. Menstrual-related pain with cramping for which she requires the use of analgesics during each cycle
- •3. Regular menstrual cycles
- •4. Routinely uses intra-vaginal tampons and is able to use tampons without an applicator
- •5. Aged 18 to 40 years inclusive
- •6. No clinically significant medical history and normal clinical examination other than the underlying pathology requiring treatment, in the opinion of the Investigator
- •7. Able to understand and complete the rating scales
- •8. Provided written informed consent
排除标准
- •A subject will be excluded from study participation if she meets any of the following criteria:
- •1. Has a history of, or known, hypersensitivity to mefenamic acid
- •2. Has a history of reactions such as asthma, urticaria, or allergic type reactions to other NSAIDs
- •3. Has received another investigational product within three months prior to screening
- •4. Is unwilling to avoid the use of any:
- •4.1. Opiate* within 24 hours
- •4.2. NSAID within 6 hours, or
- •4.3. Paracetamol within 4 hours, of starting study medication
- •5. Is pregnant, lactating, or is planning to become pregnant during the study
- •6. Is currently receiving or has received any hormonal contraception within the previous three months
- •7. Does not agree to use suitable non-hormonal contraception for the duration of the study
- •8. Has a history of Toxic Shock Syndrome (TSS)
- •9. Has a current untreated Sexually Transmitted Disease (STD) that could interfere with the study
- •10. Has, or has had, ulcerative, vesicular or papillomatous lesions of the cervix, vagina or genital area
- •11. Is known not to respond to mefenamic acid
- •12. Has signs or symptoms that contraindicate the administration of mefenamic acid
- •13. Has unresolved alcohol or drug abuse
- •14. Has severe menorrhagia which, in the opinion of the investigator, could interfere with the study
- •15. Is using complementary therapy, such as evening primrose oil, for the treatment of symptoms
- •16. Has any other condition which, in the opinion of the investigator, may interfere with the study
- •*Up to 16 mg codeine per dose (i.e., 2 co-codamol 8/500 mg tablets) is acceptable
研究者
相似试验
进行中（未招募）
不适用
A multi-centre, double-blind, placebo-controlled, randomised, parallel groupclinical trial to evaluate efficacy and safety of Actovegin® in diabetic type 2patients with symptomatic diabetic peripheral polyneuropathy - Actovegin® versus placebo in patients with diabetic polyneuropathyDiabetic PolyneuropathyMedDRA version: 8.1Level: LLTClassification code 10012685Term: Diabetic polyneuropathyEUCTR2006-004007-19-ATycomed Austria GmbH550
进行中（未招募）
不适用
A multi-centre, double-blind, placebo-controlled, randomised, parallel group study to assess the efficacy and safety of two different dosages of a herbal medicinal product (dry extract BNO-1016) in patients with acutre rhinosinusitisMulti-centre, double-blind, placebo-controlled, randomised, parallel group studyAcute rhinosinusitisMedDRA version: 9.1Level: LLTClassification code 10052106Term: RhinosinusitisEUCTR2008-002794-13-DEBionorica AG
进行中（未招募）
不适用
A multi-centre, double-blind, placebo-controlled, multiple-dose crossover proof of concept study to compare the efficacy of mefenamic acid administered vaginally and orally in healthy menstruating women with primary dysmenorrhoea requiring analgesia. - PSD508-DYS-001Primary dysmenorrhoea requiring analgesiaMedDRA version: 9.1Level: LLTClassification code 10036689Term: Primary dysmenorrhoeaEUCTR2007-001389-34-GBPlethora Solutions Limited105
进行中（未招募）
不适用
A multi-centre, double-blind, placebo-controlled, randomised, parallel group study to assess the efficacy and safety of a herbal medicinal product (dry extract BNO-1016) in patients with acute rhinosinusitis.Multi-centre, double-blind, placebo-controlled, randomised, parallel group studyAcute rhinosinusitisMedDRA version: 12.0Level: LLTClassification code 10052106Term: RhinosinusitisEUCTR2009-016682-28-DEBionorica AG
进行中（未招募）
1 期
Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipagMedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersPulmonary arterial hypertensionEUCTR2017-000216-42-SEActelion Pharmaceuticals Ltd100