CLINICAL TRIALS PROFILE FOR BALANCED SALT
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505(b)(2) Clinical Trials for Balanced Salt
Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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New Formulation | NCT00741741 ↗ | TMC278-TiDP15-C150: Trial to Examine Safety, Tolerability and Plasma Pharmacokinetics of Multiple Doses of TMC278LA. | Terminated | Tibotec Pharmaceuticals, Ireland | Phase 1 | 2008-07-01 | The purpose of this study is: to determine the safety, (local) tolerability and plasma exposure over time of single intramuscular (IM) doses of 600 and 1200 mg of a new formulation (F006) of TMC278LA, to determine the safety, (local) tolerability and long-term plasma exposure over time of 2 dose regimens of 4 monthly IM doses of a new formulation (F006) of TMC278LA., To determine the safety, (local) tolerability and long-term plasma exposure over time of 1 dose regimen of 4 monthly subcutaneous (SC) doses of a new formulation (F006) of TMC278LA. |
New Formulation | NCT01648257 ↗ | Relative Bioavailability Study of GSK1265744 Formulations | Completed | ViiV Healthcare | Phase 1 | 2012-08-01 | This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug. |
OTC | NCT02137213 ↗ | Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation | Completed | Academic Health Science Centres | Phase 2 | 2014-08-01 | At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from constipation that often affects effectiveness of MMT and increases its impact on health care system. Existing treatments include several over-the-counter medications which do not target the pathobiological basis of opioid-induced constipation and have limited effectiveness. At the same time well-known medication, naloxone, was already shown to help with constipation in patients receiving methadone for chronic pain, but was never tried in patients receiving methadone for opioid dependence. This study is aimed to try naloxone for treatment of opioid-induced constipation in MMT settings. The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced constipation. The study has a crossover design - all patients will receive one week of their regular methadone doses and one week of their regular methadone doses with naloxone added. Normal saline will be added to methadone-only formulations as placebo. Order of the weeks will be chosen randomly. Both subjects and investigators will be blinded to the study condition (i.e. whether naloxone or normal saline is added to methadone preparation on a given week). Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1 will have less severe symptoms of constipation compared to those receiving methadone only. Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause clinically significant opioid withdrawal symptoms. |
>Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Balanced Salt
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT00000574 ↗ | Ibuprofen in Sepsis Study | Completed | National Heart, Lung, and Blood Institute (NHLBI) | Phase 3 | 1990-09-01 | To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection. |
NCT00000574 ↗ | Ibuprofen in Sepsis Study | Completed | Vanderbilt University | Phase 3 | 1990-09-01 | To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection. |
NCT00000574 ↗ | Ibuprofen in Sepsis Study | Completed | Vanderbilt University Medical Center | Phase 3 | 1990-09-01 | To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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