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| Sponsored by: |
Mission Pharmacal |
|---|---|
| Information provided by: | Mission Pharmacal |
| ClinicalTrials.gov Identifier: | NCT00860093 |
Purpose
To evaluate the efficacy of MP-5971 in facilitating stone passage after Shock Wave Lithotripsy treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Nephrolithiasis |
Other: placebo Drug: MPC-5971 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
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2: Placebo Comparator
placebo identical in appearance to study drug
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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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Mission Pharmacal Company, San Antonio, TX ( Mary Walter, PhD, Chief Scientific Officer, VP Research and Development ) |
| Study ID Numbers: | MPC-5971 |
| Study First Received: | March 10, 2009 |
| Last Updated: | March 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00860093 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Kidney Calculi Urolithiasis Lithotripsy potassium compounds magnesium compounds |
|
Urologic Diseases Shock Urolithiasis Citric Acid Adjuvants, Immunologic |
Kidney Diseases Calculi Nephrolithiasis Kidney Calculi |
|
Urologic Diseases Urolithiasis Kidney Diseases Nephrolithiasis |
