Efficacy and Safety of Using MPC-5971 in Subjects Undergoing Shock Wave Lithotripsy

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of MP-5971 in facilitating stone passage after Shock Wave Lithotripsy treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mission Pharmacal

Criteria

Inclusion criteria:

• Male or female subject aged > or equal to 18 to < or equal to 70.

• Subject has undergone a computerized tomography (CT) scan within 30 days of the screening visit.

• Subject has been diagnosed with single unilateral renal calculus (target treatment stone).

• Target treatment stone, is presumed to be of calcium composition and/or uric acid composition.

• Target treatment stone is between > or equal to 5 and < or equal to 15 mm in diameter.

• Contra lateral kidney may hold a clinically inconsequential size calculus that does not require concurrent SWL treatment.

• Both kidneys are anatomically normal.

• An appropriate candidate for SWL, determined by treating physician.

• Female subjects with a negative pregnancy test, hysterectomy, tubal ligation or non-child bearing potential (post-menopausal).

• Female subjects of child bearing potential with a negative pregnancy test and taking appropriate birth control for the duration of the study.

• Urine is pyuria negative and nitrite negative on dipstick and/or negative upon microscopic evaluation.

• Subject must voluntarily consent to participate in this study and provide his/her written informed consent prior to start of any study-specific procedures.

Exclusion Criteria:

• 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 >30.

• Uncontrolled hypertension defined as subjects taking medication specific for hypertension or subject not on medication with systolic blood pressure above 140 and diastolic above 90.

• 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