A Multi-Site Placebo-Controlled Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Using MPC-5971 as Adjuvant Therapy in Subjects Undergoing Shock Wave Lithotripsy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- stone free rate after SWL treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of MP-5971 in facilitating stone passage after Shock Wave Lithotripsy treatment.
详细描述
Shock Wave Lithotripsy (SWL) is widely utilized as a first line therapy in patients with renal calculi. SWL is associated with limited morbidity, however, complications relating to stone fragment passage after treatment can occur, the most serious being ureter obstruction. In addition, the growth and agglomeration of residual fragments after SWL treatment, in approximately 40% of patients, will lead to another stone episode within 12 months. Adjunct therapy with MPC-5971 should reduce the risk of complications of residual stone fragments by facilitating passage, preventing blockage and inhibiting growth and enlargement of residual fragments. This is based on MPC-5971's ability to increase urinary inhibitors against growth and agglomeration of stone fragments and by reducing urinary saturation of calcium oxalate and uric acid. The objective is to see a decrease in fragment complications and a significant increase in the stone free rate at 3 months following SWL treatment in combination with MPC-5971.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Current or past history of cystine stones or infection stones.
- •Renal insufficiency, defined as serum creatinine value outside of the normal reference range.
- •Currently has or had hyperkalemia within the past six months, defined as serum potassium outside of the normal reference range.
- •Currently has or had hypermagnesemia within the past six months, defined as serum magnesium outside of the normal reference range.
- •Active urinary tract infection.
- •Renal calculi in an anatomically abnormal kidney; horseshoe shape, ureteropelvic junction obstruction or calyceal diverticulum.
- •Altered urinary tract anatomy such as a transplant kidney, urinary reconstruction or congenital anomaly.
- •Blood coagulopathies and or taking anticoagulants (warfarin, coumarin, heparin).
- •Taking salicylate (aspirin), including low dose aspirin for cardio-prophylaxis or other NSAID (OTC) that may increase bleeding time, within the past 7 days.
- •History of complications with previous SWL; pyelonephritis, perinephric hematoma.
- •Unsuccessful SWL treatments for previous stone within the past six months.
- •Currently has or previously had ulcers of the esophagus, stomach and/or small intestines.
- •Chronic diarrhea or has a history of diarrhea.
- •Bowel disease such as Crohn's disease, Celiac disease, fat malabsorption or Sprue.
- •Undergone any bariatric surgery procedures.
- •Obese, defined as BMI >
- •Uncontrolled hypertension defined as subjects taking medication specific for hypertension or subject not on medication with systolic blood pressure above 140 and diastolic above
- •Adrenal insufficiency (i.e., Addison's disease), adrenal tumors, and/or subjects on adrenal hormone replacement therapy.
- •Taking potassium-sparing diuretics (triamterene, amiloride, spironolactone, Midamor®, Aldactone®, Dyrenium®, Eplerenone®).
- •Taking potassium supplements (Rx or OTC) within the past 15 days.
- •Taking magnesium supplements (Rx or OTC) within the past 15 days.
- •Taken potassium citrate supplements (Rx or OTC) within the past 30 days.
- •Subject taking anticholinergic medications at entry (dicyclomine, atropine, scopolamine, oxybutynin, tolerodine, Cogentin®, Sinemet®, Robinal®, Kenadrin®, Artane®, Enablex®, Detrol®, Vesicare®, Sanctura®, Ditropan®, Oxytrol®, Bentyl®, Byclomine®, Dibent®, Di-Spaz®, or Dilomine®). (Subjects may be prescribed anticholinergics as standard of care with use of stents post entry.)
- •Subject is has taken gastrointestinal enzyme replacement therapy or proton pump inhibitors within past 30 days (Ultrase®, Creon®, Viokase®, Pancrease® MT, pancrelipase agents, Aciphex®, Nexium®, Prevacid®, Protonix®, Zegerid® Prilosec OTC®, Kapidex®, rabeprazole, esomeprazole, lansoprazole, pantoprazole, omeprazole, dexlansoprazole).
- •Women who are pregnant or lactating.
- •Subjects with a known hypersensitivity to potassium, magnesium, citrate or any excipients in the drug formulation
研究组 & 干预措施
1
MPC-5971
干预措施: MPC-5971 (Drug)
2
placebo identical in appearance to study drug
干预措施: placebo (Other)
结局指标
主要结局
stone free rate after SWL treatment
时间窗: 12 weeks
次要结局
- Reduced need for secondary procedures such as URS to clear obstructive fragments(12 weeks)
- reduced stone/fragment area (mm2),percent change from the treatment stone area (mm2)(12 weeks)
- increase in urine inhibitors(4 week and 12 week)