Clinical trial NCT01934192
Conditions: Gastroparesis
Keywords: tolerability camicinal single dose acetaminophen gastric emptying critically ill GSK962040 pharmacokinetics pharmacodynamics gut motility
Sponsor: GlaxoSmithKline
Start date: 2014-04-04; Completion date: 2016-07-08
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, parallel group, placebo-controlled and active-compared, randomized study to assess the ability of GSK962040 to enhance the delivery of enteral feed to critically ill subjects that are predisposed to developing feeding intolerance (e.g., percentage of goal volume); enhance gastric emptying in this population; and provide preliminary evidence of the drug's effect on outcomes of therapy (length of stay in the Intensive Care Unit \[ICU\], time on ventilator, ICU acquired infections, and 60-day mortality). Other aims are evaluation of GSK962040 safety, tolerability and pharmacokinetics upon repeat dosing in a critically ill population.

After meeting eligibility criteria, male and female subjects will be randomized to either receive GSK962040 (50 milligram \[mg\]) once daily (OD) via naso-gastric (NG) or orogastric (OG) feeding tube (oral solution), or placebo by the same route. If subjects develop intolerance to enteral feeding at any point up to Dose 5 of study medication (inclusive), study treatments will switch such that those originally receiving GSK962040 will receive metoclopramide (10 mg, intravenous \[iv\], every 6 hours) and those subjects originally randomized to receive placebo will receive GSK962040 (50 mg, via NG, OD). Additionally, if subjects develop intolerance prior to any treatment, they will be randomized to receive either GSK962040 (50 mg, via NG, OD) or metoclopramide (10 mg, iv, every 6 hours).

The study will consist of a screening/baseline assessment, a treatment period (up to 7 days in duration), and a 4-day post treatment safety follow-up assessment. The duration of each subject's participation in the study from screening to follow-up safety assessment will be up to approximately 2 weeks. In addition, mortality will be assessed 60 days after admission to the ICU.

Detailed description:

Arms: arm 1: Subjects in the GSK962040 Arm will receive 50 mg once daily enteral dose administered through NG tube up to 7 days. arm 2: Subjects in the placebo arm will receive once daily dose enteral dose administered through NG tube up to 7 days. arm 3: Subjects that develop intolerance and that originally received Placebo will receive 50 mg once daily enteral dose administered through NG tube + placebo IV arm 4: Subjects that develop intolerance and that originally received GSK962040 will receive metoclopramide 10 mg IV every 6 h + placebo NG
Interventions: intervention 1: GSK962040 50 mg intervention 2: Metoclopramide 10 mg intervention 3: Placebo NG intervention 4: Placebo IV
Intervention descriptions: intervention 1: GSK962040 50 mg will be administered once daily enteral dose through NG tube up to 7 days. intervention 2: Metoclopramide will be administered IV every 6 h intervention 3: Matching placebo once daily enteral dose will be administered through NG tube up to 7 days intervention 4: Placebo will be administered IV every 6 hours

Protocol documents: