Evaluation of Single Doses of GSK962040 in Critically Ill Patients With Enteral Feed Intolerance

NCT ID: NCT01039805

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-07-31

Brief Summary

The aims of MOT112571 are to assess the pharmacodynamic effects, safety, tolerability, pharmacokinetics, and potential therapeutic benefit of single doses of GSK962040 in critically ill patients with delayed gastric emptying and who are intolerant to enteral feeding.

Conditions

Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

Subjects randomized to either GSK962040 (50 mg) or placebo

Group Type: EXPERIMENTAL

GSK962040 (50 mg)

Intervention Type: DRUG

Cohort 1 = 50 mg

Placebo

Intervention Type: DRUG

matching placebo

Cohort 2

Subjects randomized to either GSK962040 (75 mg) or placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

matching placebo

GSK962040 (75 mg)

Intervention Type: DRUG

Cohort 2 = 75 mg

Interventions

GSK962040 (50 mg)

Cohort 1 = 50 mg

Intervention Type: DRUG

Placebo

matching placebo

Intervention Type: DRUG

GSK962040 (75 mg)

Cohort 2 = 75 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female between 18-85 years of age, at the time consent is obtained.
• Mechanically ventilated on the Intensive Care Unit who has become intolerant of nasogastric enteral feeding.
• intolerance of nasogastric tube feeding is defined as a gastric aspirate volume (GRV) >250 mL at least 6 hours after commencing feeding at >40 mL/hr.
• Expected to remain mechanically ventilated for at least 48 hours after enrollment and expected to survive for at least 24 hours post dose of study medication.
• Subject has a nasogastric tube for enteral feeding.
• Body weight > or = 50 kg
• Written informed consent may be obtained from a legally acceptable representative, which includes compliance with the requirements and restrictions listed in the consent form. In most cases, consent will be sought from next of kin as the subject will not be competent to give their own consent.
• Average QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
• AST and ALT < 3xULN; alkaline phosphatase and bilirubin < or = 2xULN.
• Subjects who have rapidly rising aminotransferases or for whem there is not a plausible explanation for the observed elevation will not be enrolled
• LFTs will be checked for eligibility on screening and again prior to dosing with GSK962040.

Exclusion Criteria

• Subjects that have received a gastric prokinetic agent in the previous 24 h (e.g., erythromycin, azithromycin, metoclopramide). These agents are prohibited for the duration of the study.
• Subjects whose clinical condition is deteriorating rapidly or any subject for whom the investigator does not consider there is a reasonable expectation that they will be able to complete the study.
• Subjects who are known to be infected with Hepatitis B, Hepatitis C, or HIV viruses.
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to dosing of study medication.
• Subjects with renal failure requiring replacement therapy (dialysis or filtration).
• Subjects for whom the reason for admission to ICU was an overdose (deliberate or accidental; medicinal product or not).
• Subjects with altered upper gastrointestinal tract anatomy and subjects who have undergone upper gastrointestinal tract surgery on this admission to ICU.
• Subjects with bowel obstruction or perforation.
• Subject has a gastric pacemaker
• Subject is receiving parenteral feeding
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
• Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
• Lactating females.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Adelaide, South Australia, Australia

Countries

Australia

References

Chapman MJ, Deane AM, O'Connor SL, Nguyen NQ, Fraser RJ, Richards DB, Hacquoil KE, Vasist Johnson LS, Barton ME, Dukes GE. The effect of camicinal (GSK962040), a motilin agonist, on gastric emptying and glucose absorption in feed-intolerant critically ill patients: a randomized, blinded, placebo-controlled, clinical trial. Crit Care. 2016 Aug 1;20(1):232. doi: 10.1186/s13054-016-1420-4.

Reference Type: DERIVED

PMID: 27476581 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

112571

Identifier Type: -

Identifier Source: org_study_id