CLINICAL TRIALS PROFILE FOR BALANCED SALT

505(b)(2) Clinical Trials for Balanced Salt

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.

All Clinical Trials for Balanced Salt

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.

Clinical Trial Conditions for Balanced Salt

Condition Name

Condition Name for Balanced Salt
Intervention	Trials
Healthy	172
Fasting	16
Fed	14

Condition MeSH

Condition MeSH for Balanced Salt
Intervention	Trials
Malnutrition	69
Alcoholism	17
Pain, Postoperative	15

Clinical Trial Locations for Balanced Salt

Trials by Country

Trials by Country for Balanced Salt
Location	Trials
United States	612
India	175
Italy	78
Germany	62
Canada	61

Trials by US State

Trials by US State for Balanced Salt
Location	Trials
New York	47
California	43
Texas	39
Florida	31
Ohio	28

Clinical Trial Progress for Balanced Salt

Clinical Trial Phase

Clinical Trial Phase for Balanced Salt
Clinical Trial Phase	Trials
Phase 4	169
Phase 3	112
Phase 2/Phase 3	29

Clinical Trial Status

Clinical Trial Status for Balanced Salt
Clinical Trial Phase	Trials
Completed	637
Recruiting	102
Not yet recruiting	78

Clinical Trial Sponsors for Balanced Salt

Sponsor Name

Sponsor Name for Balanced Salt
Sponsor	Trials
Dr. Reddy's Laboratories Limited	88
Ranbaxy Laboratories Limited	58
GlaxoSmithKline	31

Sponsor Type

Sponsor Type for Balanced Salt
Sponsor	Trials
Other	908
Industry	537
NIH	61