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Status:

TERMINATED

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

Lead Sponsor:

Mission Pharmacal

Conditions:

Nephrolithiasis

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

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

Detailed Description

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 pass...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2010

    Estimated Enrollment :

    135 Patients enrolled

    Trial Details

    Trial ID

    NCT00860093

    Start Date

    April 1 2010

    End Date

    December 1 2010

    Last Update

    March 7 2019

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Idaho Urologic Institute

    Meridian, Idaho, United States, 83642

    2

    Columbus Urology Research

    Columbus, Ohio, United States, 43220

    3

    Urology Clinics of North Texas, PA

    Dallas, Texas, United States, 75231