Prospective Open-Label Non Comparative Multi-Center Phase IV trial to evaluate the safety and efficacy of Spasmoproxyvon Plus capsules, a fixed dose combination of Tramadol 50mg and Dicyclomine 10mg and Acetaminophen 325mg of Wockhardt limited in management of severe acute spasmodic pain
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- Safety assessments including adverse events (AEs) and serious adverse events (SAEs).
研究概览
简要总结
This study will be a prospective, open-label, non- comparative, multi-center, phase IV trial to evaluate the safety and efficacyof Spasmoproxyvon Pluscapsules (FDC of Tramadol 50mg + Dicyclomine 10mg + Acetaminophen 325mg) ofWockhardt limited India, in subjects with severe acute spasmodic paindue to colic (dysmenorrhea, renal/ureteric colic, biliary colic, intestinal andother abdominal colic).
Assessmentof efficacy will be determined based on Clinical i.e. it will be symptomaticrelief in severity of colicky abdominal pain using Visual Analog Scale (0-100)
Clinical response will be the secondary endpoint inthis study. Clinical assessment will be made on the basis of improvement in theVisual Analog Scale (0-100) finding from baseline.
Apatient is considered a cure if signs and symptoms related to colicky abdominalpain are resolved or clinical improvement was such that there was relief inseverity of pain during overall treatment period
Allsubjects who received at least one dose of study drug shall be included in thesafety analysis. All subjects in the study will be monitored for any adverseevents and serious adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject should meet all of the below mentioned inclusion criteria for enrollment, 1.Patients of either sex aged between 18 to 65 years (inclusive) 2.Patients clinically diagnosed with severe acute spasmodic colicky pain (pain score ≥ 70 on VAS) due to dysmenorrhea, renal/ureteric colic, biliary colic, intestinal and other abdominal colic.
- •3.Subjects who understand the nature of trial and provide written informed consent for the trial 4.Subjects who are willing to comply with protocol procedures.
排除标准
- •Subjects will not be eligible for enrollment in the study if a subject meets any of the following criteria, 1.Patients with known hypersensitivity to any of the content of study medication i.e., Tramadol or dicyclomine and paracetamol.
- •2.Patients who have taken an antispasmodic agent within 7 days before enrollment in the study.
- •3.Patients with history of pathological conditions of the intestine including inflammatory bowel disease or malabsorption syndromes or gastrointestinal malignancy or gastric or intestinal surgery including vagotomy or Barretts esophagus or scleroderma confirmed by endoscopic Gastric mucosal biopsy specimens for ulcers.
- •4.Patients with signs of significant or massive GI bleeding.
- •5.Patients with severe renal disorder.
- •6.Patients with a history of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
- •7.Patient with history of glaucoma and Myasthenia 8.Patient with history of acute pancreatitis and biliary disorder other than colicky pain 9.Patient with history of any other psychiatric or other chronic diseases that will prevent compliance with the study protocol.
- •10.Patient with history of asthma and patients with risk of respiratory depression.
- •11.History or evidence of significant cardiovascular disease, any malignancy, thyroid dysfunction, epilepsy, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment.
- •12.Women of child-bearing potential who are pregnant or lactating or not following adequate contraceptive measures.
- •13.Patients who are otherwise judged inappropriate for inclusion in the study by the investigator.
结局指标
主要结局
Safety assessments including adverse events (AEs) and serious adverse events (SAEs).
时间窗: safety assessment would be done at the end of the study
次要结局
- Mean Change in VAS from baseline to end of treatment, Proportion of patients showing ≥ 50% improvement in baseline VAS pain score over end of treatment, Onset of analgesia, Duration of analgesia, Time required for analgesia, No. of study medication consumed to achieve analgesia, Physician’s and patient’s global evaluation, No. of rescue medication used(The assessment would be done at end of the study treatment)