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

NCT00860093 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2019-03-07

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Mission Pharmacal

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860093 on ClinicalTrials.gov