View clinical trials related to Gastroparesis.
Filter by:The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.
The primary objective of the study is to evaluate how patients with gastroparesis interpret the instructions, item content, and response options of a daily diary questionnaire designed to assess the key symptoms of gastroparesis.
This study is the First Time In Human study for the motilin receptor agonist, GSK1322888. GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from the motilide compound structures. The aims of this study are to assess the safety, tolerance, and pharmacokinetics of single oral doses of GSK1322888 and to identify a well-tolerated and safe dose that will accelerate gastric emptying of a 13C stable isotope-labeled test meal in healthy volunteers. The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.
The purpose of this study is to determine the absolute oral bioavailability and intravenous pharmacokinetics of GSK962040. The oral dose of 50 mg has been selected because it was well tolerated following single oral administration and it is considered to be within therapeutic dose range. The need to characterize the intravenous disposition of GSK962040 is in anticipation of drug use in special populations such as critically.
GSK962040 is a novel small molecule motilin agonist. The Phase I studies (MOT107043 and MOT109681) demonstrated that single doses of GSK962040 up to 150 mg and repeat dosing of up to 125 mg/day for 14 days were well tolerated with adverse events not occurring in greater prevalence than placebo, and no significant abnormal vital sign, ECG, or clinical laboratory findings. Pharmacokinetic parameters were linear and approximately dose proportional over the range of doses administered. Single doses of 50 mg - 150 mg GSK962040 significantly increased the rate of gastric emptying up to 40% as measured by the 13C octanoic acid stable isotope breath test. A similar effect of 50 mg and 125 mg on gastric emptying was observed throughout repeated dosing to healthy volunteers for 14-days. The aims of the present investigation (MOT114479) are to assess the pharmacodynamic effects (gastric emptying and symptoms), safety, tolerability, and pharmacokinetics of GSK962040 after 28 days of once-daily dosing in Type I and Type II diabetic subjects with gastroparesis. An additional aim is to characterize the dose/exposure - pharmacodynamic effect relationship.
Pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater. For reconstruction, pylorus-preservation (PPPD) has been shown to be technically and oncologically equivalent to the traditional whipple operation. One issue with this technique is delayed gastric emptying (DGE), which occurs in 25-70% of patients, usually emerging between day 4 and 14 after surgery. Patients with severe DGE can not only experience prolonged length of hospital stay, but are also at increased risk for other complications like aspiration or other issues related to the inability to ingest nutrition. There is vast retrospective evidence and one prospective study indicating that antecolic reconstruction of the duodenojejunostomy can improve the rate and severity of delayed gastric emptying. The investigators have conducted a prospective randomized trial in order to test this hypothesis. Patients were randomized to either undergo antecolic or retrocolic reconstruction after PPPD. On day 10 after surgery, DGE was assessed by clinical criteria. In addition, a test meal including 1g paracetamol was administered to check for clinically inapparent DGE. Of these serum samples, kinetics of intestinal peptides like GLP-1, PYY and glucagon was alos measured.
This study is designed to learn if hemin can increase the production of heme oxygenase 1 and improve gastric (stomach) emptying and symptoms in diabetic patients with slow gastric emptying (gastroparesis).
Patients undergoing whipples pancreaticoduodenectomy tend to develop delayed gastric emptying. The study compares two types of anastamosis of stomach to jejunum (supracolic and infracolic) and compares whether it influences the gastric emptying. The clinical evidence of delayed gastric emptying is correlated with objective evidence of liquid and solid emptying by radionuclide study. The study also tries to evaluate whether pancreatic leak correlates with delayed gastric emptying
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.
Kuvan® (sapropterin dihydrochloride) for Improving Gastric Accommodation in Women with Diabetic Gastroparesis (KIGA-DG)