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

PHASE2TerminatedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

November 30, 2010

Study Completion Date

December 31, 2010

Conditions
Nephrolithiasis
Interventions
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.

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.

Trial Locations (3)

43220

Columbus Urology Research, Columbus

75231

Urology Clinics of North Texas, PA, Dallas

83642

Idaho Urologic Institute, Meridian

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mission Pharmacal

INDUSTRY