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

March 5, 2019 updated by: Mission Pharmacal

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

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

Study Overview

Status

Terminated

Conditions

Intervention / 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 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

Enrollment (Actual)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Idaho Urologic Institute
    • Ohio
      • Columbus, Ohio, United States, 43220
        • Columbus Urology Research
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics Of North Texas, Pa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stone free rate after SWL treatment
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mission Pharmacal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (Estimate)

March 11, 2009

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPC-5971

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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