AzTrials
AzTrials

GastroparesisPhase 2NCT01934192

Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study

A Phase 2 study testing GSK962040 50 mg and Metoclopramide 10 mg in people with Gastroparesis, run by GlaxoSmithKline at 19 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Gastroparesis
What is being tested?
GSK962040 50 mg and Metoclopramide 10 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
19 sitesin 3 countries
Study dates
4 Apr 2014to 8 Jul 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age \& Gender: Male or female between 18 and 85 years of age inclusive, at the time of obtaining the informed consent.
  • First admitted to participating ICU within the previous 48 hours.
  • Intubated and invasively mechanically ventilated
  • Indicated to receive early EN or are already receiving EN (subject must be on EN prior to receiving study treatment)
  • Have at least one of the following
  • Clinical evidence of cardiovascular dysfunction defined as the need for vasopressor agents (e.g. norepinephrine, epinephrine, vasopressin), >5 microgram/kg/min of dopamine, or >/= 50 microgram/min phenylephrine) for greater than or equal to 2 hours;
  • Poly-trauma with an injury severity score (ISS) >=15 points
  • Acute traumatic or non-traumatic brain injury Glasgow Coma Scale (GCS) <=12, prior to the initiation of sedation.

Who cannot join

  • Subjects who are not expected to be in the ICU and alive for at least 48 hrs from point of screening.
  • Subjects with acute hepatitis (e.g. acute hepatitis B or C) or severe chronic liver disease (e.g. Child Pugh class C cirrhosis) will be excluded
  • Liver function tests: If Alanine aminotransferase (ALT) >=8x upper limit of normal (ULN); OR If ALT >5-8x ULN and bilirubin >2<=3 ULN or bilirubin >3x ULN (Include only if bilirubin <1.5xULN); OR If ALT <=5xULN and Bilirubin >3xULN (Include only if ALT <=3xULN and Bilirubin >2 <=3xULN)
  • Subjects who have received a gastric prokinetic agent in the previous 12 hours (e.g., erythromycin, azithromycin, metoclopramide, domperidone).
  • QT duration corrected for heart rate (QTc) >480 ms. QTcF is the recommended correction factor for all sites. If QT duration corrected for heart rate by Fridericia's formula (QTcF) is not possible to obtain or calculate, QT duration corrected for heart rate by Bazett's formula (QTcB) or machine or manual over read, may be obtained after consultation with the medical monitor. The QT correction formula used to determine inclusion and discontinuation should be the same throughout the study.
  • Use of strong Cyp3A4 inhibitors
Show all 18Show fewer
  • Subjects who require renal replacement therapy or with an estimated glomerular filtration rate (GFR) of <30 mL/min byCockroft-Gault calculation).
  • Subjects who have a history of or who have undergone major esophageal or gastric surgery on this admission (major lower abdominal surgery will not result in exclusion unless this carries a contraindication to enteral feeding).
  • Subjects with an absolute contraindication to enteral nutrition e.g. subjects with ongoing bowel obstruction or perforation.
  • Subject has a gastric pacemaker
  • Pregnant or lactating females
  • 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.
  • Concurrent enrollment in other interventional study involving a novel (i.e.unapproved or experimental) chemical or biopharmaceutical entity.
  • Previous randomization in this study
  • Subjects for whom the reason for admission to ICU was an overdose (deliberate or accidental; medicinal product or not).
  • Subjects with an untreated pheochromocytoma.
  • Subjects with a past history of a seizure disorder (e.g., epilepsy) and is currently receiving anti-epileptic treatment for their seizure disorder, ongoing refractory, or sustained seizure disorder (prophylactic use for head injury/isolated new seizure maintained on anti-seizure meds in ICU acceptable).
  • Subjects taking drugs likely to cause extrapyramidal reactions.

Trial locations and contacts

19 sites in 3 countries.

19 sites in 3 countries

Canada11 sites

  • GSK Investigational Site

    Calgary, Alberta, T1Y 6J4

  • GSK Investigational Site

    Calgary, Alberta, T2N 2T9

  • GSK Investigational Site

    Hamilton, Ontario, L8L 2X2

  • GSK Investigational Site

    Kingston, Ontario, K7L 2V7

  • GSK Investigational Site

    Montreal, Quebec, H2X 3J4

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Ottawa, Ontario, K1Y 4E9

  • GSK Investigational Site

    Québec, Quebec, G1J 1Z4

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G5

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    Toronto, Ontario, M5G 1X5

Other trials in Canada

United States4 sites

  • GSK Investigational Site

    Augusta, Georgia, 30909

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

Other trials in United States

Australia4 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Randwick, New South Wales, 2031

  • GSK Investigational Site

    Southport, Queensland, 4215

  • GSK Investigational Site

    Woodville, South Australia, 5011

Other trials in Australia

About this study

Official title: NUTRItional Adequacy Therapeutic Enhancement in the Critically Ill: A Randomized Double Blind, Placebo-controlled Trial of the Motilin Receptor Agonist GSK962040. The NUTRIATE Study

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.

Conditions
Gastroparesis
Being tested
GSK962040 50 mg, Metoclopramide 10 mg, Placebo NG, Placebo IV
Keywords
tolerability, camicinal, single dose, acetaminophen, gastric emptying, critically ill, GSK962040, pharmacokinetics, pharmacodynamics, gut motility
Medical subject headings
Gastroparesis, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK962040 50 mgDrug

    GSK962040 50 mg will be administered once daily enteral dose through NG tube up to 7 days.

  • Metoclopramide 10 mgDrug

    Metoclopramide will be administered IV every 6 h

  • Placebo NGDrug

    Matching placebo once daily enteral dose will be administered through NG tube up to 7 days

  • Placebo IVDrug

    Placebo will be administered IV every 6 hours

Study groups in NCT01934192
Study groupRoleWhat they receive
Initial randomization: GSK962040 ArmExperimentalSubjects in the GSK962040 Arm will receive 50 mg once daily enteral dose administered through NG tube up to 7 days.
Receives: Drug: GSK962040 50 mg
Initial randomization: Placebo ArmPlacebo comparatorSubjects in the placebo arm will receive once daily dose enteral dose administered through NG tube up to 7 days.
Receives: Drug: Placebo NG
Treatment change due to intolerance: GSK962040 ArmExperimentalSubjects that develop intolerance and that originally received Placebo will receive 50 mg once daily enteral dose administered through NG tube + placebo IV
Receives: Drug: GSK962040 50 mg; Drug: Placebo IV
Treatment change due to intolerance: Metoclopramide ArmActive comparatorSubjects that develop intolerance and that originally received GSK962040 will receive metoclopramide 10 mg IV every 6 h + placebo NG
Receives: Drug: Metoclopramide 10 mg; Drug: Placebo NG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population

    The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% confidence interval (CI) were estimated and Analysis of Covariance (ANCOVA) model was used for analysis.

    Measured: Up to Day 7

  2. Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population

    The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.

    Measured: Up to Day 7

Secondary outcomes (35)

  1. Average Percentage Goal Calories Delivered Prior to Development of Intolerance

    The average percentage goal calories received via EN was defined as the percent of goal calories received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total calories received via EN during the on treatment period prior to intolerance divided by total prescribed calories. 'Prior to intolerance' means 'prior to start of intolerance treatment. The average percentage goal calories received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.

    Measured: Up to Day 7

  2. Average Percentage Goal Protein Delivered Prior to Development of Intolerance

    The average percentage goal protein received via EN was defined as the percent of goal protein received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total protein received via EN during the on treatment period prior to intolerance divided by total prescribed protein. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal protein received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.

    Measured: Up to Day 7

  3. Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance

    Time required for the delivery of 80 percent prescribed calories prior to intolerance was calculated using Kaplan-Meier estimates for time variable. Prior to intolerance was defined as prior to start of intolerance treatment. Participants who did not reach delivery of 80 percent prescribed calories were censored at the last day on which they received randomized treatment and with available nutritional data.

    Measured: Up to Day 7

  4. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE.

    Measured: up to 23 days

  5. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SBP and DBP were measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till 23 days). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, SBP and DBP were measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the standard deviation (SD) was set to missing.

    Measured: Up to 23 days

  6. Change From Baseline in Heart Rate (HR)

    HR was measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till Day 23). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, HR was measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  7. Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values

    12-lead ECGs was done at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and at follow up (till Day 23) that automatically calculates corrected QT (QTc), QTcF (QT duration corrected for heart rate by Fridericia's formula) and QTcB (QT duration corrected for heart rate by Bazett's formula) intervals. Three ECGs approximately 5 min apart were collected prior to dose 1and single recordings were made at other time points. On Day 1ECGs were collected at pre-dose (up to 6 hrs) and 2 hr post treatment. Number of participants with maximum increase from Baseline were collected and participants showed increase in 3 parameters namely QTc, QTcB and QTcF. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).

    Measured: Up to 23 days

  8. Change From Baseline in Albumin and Total Protein Levels

    Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline, Day 2-7 and follow-up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  9. Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels

    Blood samples were collected to evaluate change from Baseline in alk.phosp., ALT, AST and GGT values at Baseline, Day 1- Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  10. Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels

    Blood samples were collected to evaluate change from Baseline in total and direct bilirubin, creatinine and uric acid values at Baseline, Day 2- Day 7 and at follow up (Till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  11. Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values

    Blood samples were collected to evaluate change from Baseline in calcium, chloride, carbon dioxide, glucose, potassium, sodium, BUN values at Baseline, up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  12. Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels

    Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet and WBC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  13. Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels

    Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  14. Change From Baseline in Hematocrit Level

    Blood samples were collected to evaluate change from Baseline in hematocrit values at Baseline up to Day 7 and follow up (till day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  15. Change From Baseline in Mean Corpuscle Volume (MCV) Levels

    Blood samples were collected to evaluate change from Baseline in MCV values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  16. Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count

    Blood samples were collected to evaluate change from Baseline in RBC and reticulocytes values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  17. Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels

    Blood samples were collected to evaluate change from Baseline in MCH values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.

    Measured: Up to 23 days

  18. Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance)

    Blood samples for pharmacokinetic (PK) analysis were collected at Baseline, and at Day 2 or at Day 3 (OR very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with acetaminophen and Cmax was defined as maximum observed plasma concentration of acetaminophen. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Due to change in sampling schedule, samples were only obtained to 4 hours. Only those participants available at the specified time points were analyzed (represented by n= x in the category titles).

    Measured: At Day 2

  19. Log Transformed AUC[0-60] of Acetaminophen

    Blood samples for PK analysis were collected at Baseline, and at 60 min. at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of acetaminophen was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)

    Measured: At Day 2

  20. Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG)

    Blood samples for PK analysis were collected at Baseline, and at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of 3-OMG was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)

    Measured: At Day 2

  21. Log Transformed C60 of 3-OMG

    Blood samples for PK analysis were collected at Baseline and at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained)prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with 3-OMG. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Cmax was not analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).

    Measured: At Day 2

  22. Derived Tmax of 3-OMG Post Intolerance

    Blood samples for PK analysis were collected at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained) post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of 3-OMG.

    Measured: At Day 2

  23. Percentage of Participants That Became Intolerant

    Percentage of participants that became intolerant was calculated. Those participants who developed intolerance were assessed to characterize gastric emptying (GE). Participants who did not develop intolerance were censored at the time of the last available Gastric Residual Volume (GRV) measurement.

    Measured: Up to Day 7

  24. Time to Development of Feeding Intolerance

    Time required for the development of feeding intolerance was calculated using Kaplan-Meier estimates for time variable. Median and quartiles were not calculable due to the small number of participants developing EN intolerance and mean and standard error of mean were presented.

    Measured: Up to Day 7

  25. GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen

    GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. AUC (0-60) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.

    Measured: Day 2

  26. GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen

    GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. Cmax was calculated and data was presented for pre-dose Visit(day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.

    Measured: Baseline, Day 2, Day 3, Day 4

  27. GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG

    GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. AUC(0-60) and AUC (0-240) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.

    Measured: Baseline, Day 2, Day 3, Day 4

  28. GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG

    GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. C60 was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.

    Measured: Baseline, Day 2, Day 3, Day 4

  29. Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes

    The total number of vomiting, regurgitation and macroaspiration episodes were categorized separately for prior to and post intolerance. Intolerance was considered as start of intolerance treatment. Only the records with non-zero counts were listed.

    Measured: up to 23 days

  30. Total GRV for 24 hr Period

    Total GRV for each 24 hr period up to 7 days were assessed to determine the effect of GSK962040 vs. Placebo upon the daily GRV. Intolerance was defined as start of the intolerance treatment. The total GRV for each 24hr period was the sum of all available GRV measurements during the period. The 24hr was counted using the same 24hr clock as for the collection of nutritional data.

    Measured: Up to Day 7

  31. Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance

    Blood samples for PK analysis were collected at Day 2, Day 3, Day 4, Day 7 prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. PK Population comprised of participants in the 'Safety' population for whom a PK sample of Camicinal was obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).

    Measured: Day 2, Day 3, Day 4, Day 7

  32. Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance

    Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. NA indicates that data were not available. SD was not provided if n < 3.

    Measured: Day 2 and Day 4

  33. Derived Tmax of GSK962040 Post Intolerance

    Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of Camicinal.NA indicates that data were not available. SD was not provided if n<3.

    Measured: Day 2 and Day 4

  34. Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance

    Blood samples for PK analysis were collected at Baseline, and at Day 2 and Day 4 post development of intolerance. AUC from time zero extrapolated to infinite time [AUC(0-inf)] was not analyzed.

    Measured: Day 2 and Day 4

  35. Derived Accumulation Ratio (RO) of GSK962040 Post Intolerance

    To estimate the extent of accumulation after repeat dosing, the observed accumulation ratio (Ro) was assessed.

    Measured: Baseline, Day 2, Day 3, Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2013 (estimated)
  2. Study start4 Apr 2014
  3. Primary completion8 Jul 2016
  4. Study completion8 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01934192
Sponsor's protocol ID
113445
Status last verified
Oct 2017
First submitted
29 Aug 2013
Last updated
11 Dec 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK962040 50 mg and Metoclopramide 10 mg in people with Gastroparesis, run by GlaxoSmithKline at 19 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Canada, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population (time frame: Up to Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01934192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in