drugset / Trial / NCT00860093
Efficacy and Safety of Using MPC-5971 in Subjects Undergoing Shock Wave Lithotripsy
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy of MP-5971 in facilitating stone passage after Shock Wave Lithotripsy treatment.
Timeline
- Start
- 2010-04
- Primary completion
- 2010-11
- Completion
- 2010-12
Outcome
Outcome not reported
Stopped (Business): “Sponsor Corporate Business Decision”
Publications
- Background Koenig K, Padalino P, Alexandrides G, Pak CY. Bioavailability of potassium and magnesium, and citraturic response from potassium-magnesium citrate. J Urol. 1991 Feb;145(2):330-4. doi: 10.1016/s0022-5347(17)38330-1.
- Background Pak CY, Koenig K, Khan R, Haynes S, Padalino P; New Collective Author. Physicochemical action of potassium-magnesium citrate in nephrolithiasis. J Bone Miner Res. 1992 Mar;7(3):281-5. doi: 10.1002/jbmr.5650070306.
- Background Ettinger B, Pak CY, Citron JT, Thomas C, Adams-Huet B, Vangessel A. Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. J Urol. 1997 Dec;158(6):2069-73. doi: 10.1016/s0022-5347(01)68155-2.
- Background Gonzalez GB, Pak CY, Adams-Huet B, Taylor R, Bilhartz LE. Effect of potassium-magnesium citrate on upper gastrointestinal mucosa. Aliment Pharmacol Ther. 1998 Jan;12(1):105-10. doi: 10.1046/j.1365-2036.1998.00280.x.
- Background Ruml LA, Wuermser LA, Poindexter J, Pak CY. The effect of varying molar ratios of potassium-magnesium citrate on thiazide-induced hypokalemia and magnesium loss. J Clin Pharmacol. 1998 Nov;38(11):1035-41. doi: 10.1177/009127009803801108.
- Background Ruml LA, Gonzalez G, Taylor R, Wuermser LA, Pak CY. Effect of varying doses of potassium-magnesium citrate on thiazide-induced hypokalemia and magnesium loss. Am J Ther. 1999 Jan;6(1):45-50. doi: 10.1097/00045391-199901000-00007.
- Background Ruml LA, Pak CY. Effect of potassium magnesium citrate on thiazide-induced hypokalemia and magnesium loss. Am J Kidney Dis. 1999 Jul;34(1):107-13. doi: 10.1016/s0272-6386(99)70115-0.
- Background Wuermser LA, Reilly C, Poindexter JR, Sakhaee K, Pak CY. Potassium-magnesium citrate versus potassium chloride in thiazide-induced hypokalemia. Kidney Int. 2000 Feb;57(2):607-12. doi: 10.1046/j.1523-1755.2000.00881.x.
- Background Jaipakdee S, Prasongwatana V, Premgamone A, Reungjui S, Tosukhowong P, Tungsanga K, Suwantrai S, Noppawinyoowong C, Maskasame S, Sriboonlue P. The effects of potassium and magnesium supplementations on urinary risk factors of renal stone patients. J Med Assoc Thai. 2004 Mar;87(3):255-63.
- Background Tosukhowong P, Tungsanga K, Phongudom S, Sriboonlue P. Effects of potassium-magnesium citrate supplementation on cytosolic ATP citrate lyase and mitochondrial aconitase activity in leukocytes: a window on renal citrate metabolism. Int J Urol. 2005 Feb;12(2):140-4. doi: 10.1111/j.1442-2042.2005.01001.x.
- Background Sriboonlue P, Jaipakdee S, Jirakulsomchok D, Mairiang E, Tosukhowong P, Prasongwatana V, Savok S. Changes in erythrocyte contents of potassium, sodium and magnesium and Na, K-pump activity after the administration of potassium and magnesium salts. J Med Assoc Thai. 2004 Dec;87(12):1506-12.
- Background Odvina CV, Mason RP, Pak CY. Prevention of thiazide-induced hypokalemia without magnesium depletion by potassium-magnesium-citrate. Am J Ther. 2006 Mar-Apr;13(2):101-8. doi: 10.1097/01.mjt.0000149922.16098.c0.
- Background Zerwekh JE, Odvina CV, Wuermser LA, Pak CY. Reduction of renal stone risk by potassium-magnesium citrate during 5 weeks of bed rest. J Urol. 2007 Jun;177(6):2179-84. doi: 10.1016/j.juro.2007.01.156.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MPC-5971 | Small molecule | 20 meq | Oral |
| Subject | MPC-5971 | Small molecule | 40 meq | Oral |
| Subject | MPC-5971 | Small molecule | 60 meq | Oral |