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

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ClinicalTrials.gov Identifier: NCT00860093
Recruitment Status : Terminated (Sponsor Corporate Business Decision)
First Posted : March 11, 2009
Last Update Posted : March 22, 2017
Sponsor:
Information provided by:
Mission Pharmacal

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

Condition or disease Intervention/treatment Phase
Nephrolithiasis Other: placebo Drug: MPC-5971 Phase 2

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones Shock

Arm Intervention/treatment
Experimental: 1
MPC-5971
Drug: MPC-5971
After SWL treatment subjects will be randomized to receive either MPC-5971 or placebo. Two tablets of MPC-5971 or placebo will be taken orally twice a day (bid). This will give a daily dosage equal to 40 mEq of potassium, 20 mEq of magnesium and 60 mEq of citrate. MPC-5971 or placebo will be taken bid for 90 days beginning immediately after SWL treatment.

Placebo Comparator: 2
placebo identical in appearance to study drug
Other: placebo
After SWL treatment subjects will be randomized to receive either MPC-5971 or placebo. Two tablets of MPC-5971 or placebo will be taken orally twice a day (bid). This will give a daily dosage equal to 40 mEq of potassium, 20 mEq of magnesium and 60 mEq of citrate. MPC-5971 or placebo will be taken bid for 90 days beginning immediately after SWL treatment.




Primary Outcome Measures :
  1. stone free rate after SWL treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. increase in urine inhibitors [ Time Frame: 4 week and 12 week ]
  2. Reduced need for secondary procedures such as URS to clear obstructive fragments [ Time Frame: 12 weeks ]
  3. reduced stone/fragment area (mm2),percent change from the treatment stone area (mm2) [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860093


Locations
United States, Idaho
Idaho Urologic Institute
Meridian, Idaho, United States, 83642
United States, Ohio
Columbus Urology Research
Columbus, Ohio, United States, 43220
United States, Texas
Urology Clinics of North Texas, PA
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Mission Pharmacal

Publications:

Responsible Party: Mary Walter, PhD, Chief Scientific Officer, VP Research and Development, Mission Pharmacal Company, San Antonio, TX
ClinicalTrials.gov Identifier: NCT00860093     History of Changes
Other Study ID Numbers: MPC-5971
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Keywords provided by Mission Pharmacal:
Kidney Calculi
Urolithiasis
Lithotripsy
potassium compounds
magnesium compounds

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical